AccessGUDID - DEVICE: H&H (04719884330122)

GUDID

Device Identifier (DI) Information

Brand Name: H&H
Version or Model: HW0505
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HW0505
Company Name: TRONJEN MEDICAL TECHNOLOGY INC.

Primary DI Number: 04719884330122
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 657496877 *Terms of Use
Previous DI: 04719859641925

Device Description: Hydration healing for wounds 1. absorbing exudate (reduce the number of dressing changes, to avoid interference with woundhealing) 2. Non-adherent and Non-linting (Easy to remove, won’t cause wound trama) 3. Perfect conformity (Conform to wound’sfigure perfectly, patients feel comfortable in their daily movements)

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?
47771	Scar-management dressing, single-use	A covering/substance made of, or coated with, a synthetic polymer material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of a flexible or elastic sheet/film, foam, or gel that occludes the skin to hydrate and reduce/prevent red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; devices/accessories associated with application may be included (e.g., massage ball). After application, this device cannot be reused.	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
Length: 5 Centimeter
Width: 5 Centimeter

Device Record Status

Public Device Record Key: 224f6128-0c40-4f7f-a9d8-747e40684d81
Public Version Date: February 16, 2024
Public Version Number: 2
DI Record Publish Date: July 20, 2023