AccessGUDID - DEVICE: H&H (04719884331402)

GUDID

Device Identifier (DI) Information

Brand Name: H&H
Version or Model: WG0030
Commercial Distribution Status: In Commercial Distribution
Catalog Number: WG0030
Company Name: TRONJEN MEDICAL TECHNOLOGY INC.

Primary DI Number: 04719884331402
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 657496877 *Terms of Use

Device Description: "H&H" Wound Gel (Sterile) is a transparent gel dressing with an amorphous structure, suitable for irregularly shaped wounds. The formulation is designed to achieve isotonicity, allowing the gel to cover the wound bed, providing a moist wound healing environment, and promoting the migration of new epidermal cells. Carboxymethyl cellulose, combined with glycerol and hyaluronic acid, not only helps absorb wound exudate and blood but also forms a moist gel protective layer on the wound bed, providing an optimal moist healing environment while reducing the risk of infection by acting as a barrier to foreign materials.

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):	No
Over the Counter (OTC):	Yes
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?
47764	Wound hydrogel dressing, non-antimicrobial	A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations 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; it does not include an antimicrobial agent(s). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 30 Milliliter

Device Record Status

Public Device Record Key: 0c63b2b1-610d-4ce3-853d-92c1bd2db2f6
Public Version Date: July 28, 2023
Public Version Number: 1
DI Record Publish Date: July 20, 2023