AccessGUDID - DEVICE: H&H (04719859642052)

GUDID

Device Identifier (DI) Information

Brand Name: H&H
Version or Model: SH2106
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SH2106
Company Name: TRONJEN MEDICAL TECHNOLOGY INC.

Primary DI Number: 04719859642052
Issuing Agency: GS1
Commercial Distribution End Date: July 12, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 657496877 *Terms of Use

Device Description: Effective treatment for scar 1. Maintain proper moist environment 2. Support and close the wound 3. Tissue well arrayed, reduce scar proliferation.

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
NAD	Dressing, Wound, Occlusive

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: 21 Centimeter
Width: 6 Centimeter

Device Record Status

Public Device Record Key: aa25502d-19c0-43db-890b-9382fae3f8c6
Public Version Date: July 12, 2024
Public Version Number: 5
DI Record Publish Date: June 12, 2020