AccessGUDID - DEVICE: revyve Antimicrobial Wound Gel (00628451217701)

GUDID

Device Identifier (DI) Information

Brand Name: revyve Antimicrobial Wound Gel
Version or Model: CWG030R
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Kane Biotech Inc

Primary DI Number: 00628451217701
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 201759276 *Terms of Use

Device Description: A white, odourless hydrogel that provides a moist wound environment conducive to wound healing. The gel provides preservative properties through an antimicrobial (PHMB) to help inhibit microbial colonization within the gel during shelf storage. Chronic wounds are known to contain non-viable tissue. The gel can facilitate debridement through a moist wound environment.

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
59522	Wound hydrogel dressing, antimicrobial	A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K223259	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Weight: 28 Gram

Device Record Status

Public Device Record Key: 2fd5d077-eb5e-40b7-8a53-3bea30f03628
Public Version Date: December 04, 2023
Public Version Number: 3
DI Record Publish Date: October 11, 2023