AccessGUDID - DEVICE: TransCyte (00618474000046)

GUDID

Device Identifier (DI) Information

Brand Name: TransCyte
Version or Model: 10633
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ORGANOGENESIS INC.

Primary DI Number: 00618474000046
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 152165817 *Terms of Use

Device Description: TRANSCYTE® is a human fibroblast-derived temporary skin substitute consisting of a polymer membrane and donated neonatal human fibroblast cells cultured under aseptic conditions in vitro on a nylon mesh. Prior to cell growth, this nylon mesh is coated with porcine dermal collagen and bonded to a polymer membrane (silicone). This membrane provides a transparent synthetic epidermis when applied. As fibroblasts proliferate within the nylon mesh, they secrete human dermal collagen, matrix proteins and growth factors. Following freezing, no cellular metabolic activity remains; however, the tissue matrix and bound growth factors are left intact. The human fibroblast-derived temporary skin substitute provides a temporary protective barrier. TRANSCYTE is transparent and allows direct visual monitoring of the wound bed.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	Yes

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46170	Skin regeneration template, human-/animal-derived	A sterile covering used as a temporary skin substitute on wounds (e.g., diabetic or venous insufficiency ulcers) or burns that involve the dermis, and that provides a matrix, typically of living cells (fibroblasts) and/or structural proteins, to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device contains human- and animal-derived products (e.g., bovine, porcine), or only animal-derived products. It may be mono- or bi-layered, and may contain natural and synthetic materials. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MGR	Dressing, Wound And Burn, Interactive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BP960700	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -70 and -20 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d55af25a-ae34-474d-8225-2b0de0781efa
Public Version Date: December 03, 2019
Public Version Number: 4
DI Record Publish Date: January 12, 2018