AccessGUDID - DEVICE: PowerHeal Kit (00810198031508)

GUDID

Device Identifier (DI) Information

Brand Name: PowerHeal Kit
Version or Model: 2"x2" SL, Energel & Tegaderm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PTK-2020-04
Company Name: Vomaris Wound Care, Inc.

Primary DI Number: 00810198031508
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080126901 *Terms of Use

Device Description: PowerHeal Kit, 2"x2" Single Layer, Energel & Tegaderm

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
Kit:	Yes
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?
62983	Bioelectric wound dressing	A sterile wound covering containing microcell batteries [e.g., based on silver (Ag)/zinc(Zn)] designed to mimic a physiologic electric field in the presence of a conductive medium (e.g. saline, hydrogel, or wound exudate) to destroy microbial pathogens (antimicrobial) at the dressing surface and help reduce the risk of wound infection. It is intended to cover partial- and full-thickness wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and help create a moist wound-healing environment. It is in the form of a flat sheet/pad, may be designed to absorb wound exudates, but does not have wound-nonadherent properties. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

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: Yes
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
No Device Sizes

Device Record Status

Public Device Record Key: b19ceb11-77f6-4d17-bf5c-94084b4f479d
Public Version Date: March 08, 2024
Public Version Number: 1
DI Record Publish Date: February 29, 2024