TransCyte

GUDID 00618474000046

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.

ORGANOGENESIS INC.

Skin regeneration template, human-/animal-derived Skin regeneration template, human-/animal-derived

• Primary Device ID: 00618474000046
• NIH Device Record Key: d55af25a-ae34-474d-8225-2b0de0781efa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TransCyte
• Version Model Number: 10633
• Company DUNS: 152165817
• Company Name: ORGANOGENESIS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -70 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00618474000046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BP960700

FDA Product Code

• MGR: Dressing, Wound And Burn, Interactive
• PFC: Cultured Human Cell Skin Dressing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-03
• Device Publish Date: 2018-01-12

Devices Manufactured by ORGANOGENESIS INC.

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• 00618474000459 - PuraPly™ Antimicrobial Wound Matrix: 2021-04-14 PuraPly™ Antimicrobial Wound Matrix consists of collagen sheets coated with polyhexamethylenebiguanide hydrochloride (PHMB) in
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• 00618474000206 - PuraForce™: 2020-05-06 PuraForce ™ tendon reinforcement matrix is a resorbable collagen based material intended for implantation to reinforce soft ti