AccessGUDID - DEVICE: Nuvagen Collagen Powder (00618474000510)

GUDID

Device Identifier (DI) Information

Brand Name: Nuvagen Collagen Powder
Version or Model: 2002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2002
Company Name: Cpn Biosciences, LLC

Primary DI Number: 00618474000510
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079896008 *Terms of Use

Device Description: A sterile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. Nuvagen Collagen Powder is a hydrophilic, hydrocolloid wound-powder with a collagen base. It is an insoluble fibrous type I bovine derived from cowhide.

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):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45023	Collagen wound matrix dressing	A sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template 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 is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGN	Wound Dressing With Animal-Derived Material(S)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K910944	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 85 Degrees Fahrenheit
Special Storage Condition, Specify: Store in a dry place

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8d4ad3c1-5826-4aba-99ca-ff756b673167
Public Version Date: October 02, 2023
Public Version Number: 1
DI Record Publish Date: September 22, 2023