Dermagraft

Basic Information

• Brand Name: Dermagraft
• Primary DI: 00618474000015
• Version / Model: 1
• Company Name: ORGANOGENESIS INC.
• Labeler DUNS: 152165817
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 17ff0e99-7199-44d1-b844-9bde6d4ca4e7

Device Description

Dermagraft is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six weeks duration, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Dermagraft should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: Yes
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PFC	Cultured Human Cell Skin Dressing	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00618474000015	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
BP003600	00

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -85 – -65 Degrees Celsius