AccessGUDID - DEVICE: Apligraf (00618474000008)

GUDID

Device Identifier (DI) Information

Brand Name: Apligraf
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ORGANOGENESIS INC.

Primary DI Number: 00618474000008
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 152165817 *Terms of Use

Device Description: Apligraf is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full thickness skin ulcers due to venous insufficience of greater than one month duration and which have not adequately responded to conventional ulcer therapy. Apligraf is also indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three weeks duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.

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
PFC	Cultured Human Cell Skin Dressing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 68 and 73 Degrees Fahrenheit
Special Storage Condition, Specify: Do Not Open Bag Until Immediately Prior to Use

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: df48bbf4-5d9d-461a-bc55-c3fa548b0a53
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2014