Skin Biopsy Transport Kit

Primary DI
00860004093008
Brand
Skin Biopsy Transport Kit
Company
VERICEL CORPORATION
Model
0
Device description
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)
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDWContainer, Specimen Mailer And Storage, Temperature Controlled, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDWContainer, Specimen Mailer And Storage, Temperature Controlled, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860004093008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860004093008008600040930088600040930080860004093008

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, preservation solution, sterileA sterile covered plastic receptacle containing a preservative (e.g., cell or nucleic acid preservation solution) intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) collected from any body part for in vitro diagnostic procedures [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do 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
Special Storage Condition, Specify00Do not freeze biopsy kit or contents
Special Storage Condition, Specify00Do 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, Specify00Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
Special Storage Condition, Specify00Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 453-6948customercare@vcel.com

Regulatory Flags#

DUNS number
079745570
Device count
1
Premarket exempt
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850037506207Skin Biopsy Transport KitVERICEL CORPORATIONKDW2022-12-08
00850037506194Cartilage Biopsy Transport KitVERICEL CORPORATIONKDW2022-12-08
00860004093015Cartilage Biopsy Transport KitVERICEL CORPORATIONKDW2020-09-24
M7557820501gSourceGSOURCE LLCKDW2017-03-31