Skin Biopsy Transport Kit

GUDID 00860004093008

The Skin Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live skin biopsy and return it to the Vericel Cambridge Manufacturing Facility for the production of EPICEL - (Container, specimen mailer and storage, temperature controlled, sterile)

VERICEL CORPORATION

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Primary Device ID00860004093008
NIH Device Record Keyf042a1e0-3f2b-4213-8248-765bbdb531f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameSkin Biopsy Transport Kit
Version Model Number0
Company DUNS079745570
Company NameVERICEL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com
Phone(800) 453-6948
Emailcustomercare@vcel.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze biopsy kit or contents
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
Special Storage Condition, SpecifyBetween 0 and 0 *Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139

Device Identifiers

Device Issuing AgencyDevice ID
GS100860004093008 [Primary]

FDA Product Code

KDWContainer, Specimen Mailer And Storage, Temperature Controlled, Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-02
Device Publish Date2020-09-24

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00850037506170 - Blood Collection Kit2022-10-03 The Blood Collection Kit is intended to provide a way to collect and transport venous blood samples to a biobanking facility. Th
00850037506095 - Sterilization Tray2022-07-25
00860004093008 - Skin Biopsy Transport Kit2020-10-02The Skin Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live skin biopsy and return it to the Vericel Cambridge Manufacturing Facility for the production of EPICEL - (Container, specimen mailer and storage, temperature controlled, sterile)
00860004093008 - Skin Biopsy Transport Kit2020-10-02 The Skin Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live skin biopsy and
00860004093015 - Cartilage Biopsy Transport Kit2020-10-02 The Cartilage Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live cartilage b

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