Skin Biopsy Transport Kit

Primary DI
10850037506207
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
2022-12-08
Public version status
New
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
10850037506207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085003750620710850037506207

GMDN Terms#

Term, Definition table
TermDefinition
Specimen container mailer, insulatedA non-sterile tube, box, or envelope designed to transport a specimen container/receptacle by mail and to provide protection and insulation for the container and its specimen content. It can be used for mail services internal or external to healthcare facilities. It includes insulation intended to provide a thermal barrier between the specimen and the environment to preserve temperature-sensitive samples. The device is also intended to protect the specimen container (e.g., glass vial, bottle, tube, or slide) from adverse conditions that could cause breakage. 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

Contacts#

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

Regulatory Flags#

DUNS number
079745570
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850037506132MACI Surgical Implantation KitN/A2022-11-09
00850037506101Cutting Block890542022-11-09
00850037506057MACI Arthroscopic Instruments82024N/A2024-09-18
00850037506224MACI Arthroscopic Instruments82034N/A2024-09-18
00850037506262MACI Arthroscopic Instruments82038N/A2024-09-18
00850037506002MACI Arthroscopic Instruments82032N/A2024-08-26
00850037506019MACI Arthroscopic Instruments82023N/A2024-08-26
00850037506026MACI Arthroscopic Instruments82021N/A2024-08-26
00850037506033MACI Arthroscopic Instruments82020N/A2024-08-26
00850037506040MACI Arthroscopic Instruments82022N/A2024-08-26
00850037506064MACI Arthroscopic Instruments82026N/A2024-08-26
00850037506088MACI Arthroscopic Instruments82016N/A2024-08-26
00850037506217MACI Arthroscopic Instruments82033N/A2024-08-26
00850037506231MACI Arthroscopic Instruments82035N/A2024-08-26
00850037506248MACI Arthroscopic Instruments82036N/A2024-08-26
00850037506255MACI Arthroscopic Instruments82037N/A2024-08-26
00850037506279MACI Arthroscopic Instruments89060N/A2024-08-26
00860004093022MACI Arthroscopic Instruments82017N/A2024-08-26
00860004093039MACI Arthroscopic Instruments82018N/A2024-08-26
00860004093046MACI Arthroscopic Instruments82025N/A2024-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850037506194Cartilage Biopsy Transport KitVERICEL CORPORATIONKDW2022-12-08
00860004093008Skin Biopsy Transport KitVERICEL CORPORATIONKDW2020-09-24
00860004093015Cartilage Biopsy Transport KitVERICEL CORPORATIONKDW2020-09-24
M7557820501gSourceGSOURCE LLCKDW2017-03-31