AccessGUDID - DEVICE: Anscare Scar Reduction Silicone Gel C+ (14719745503006)

GUDID

Device Identifier (DI) Information

Brand Name: Anscare Scar Reduction Silicone Gel C+
Version or Model: SC201-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BENQ MATERIALS CORP.

Primary DI Number: 14719745503006
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 657476292 *Terms of Use

Device Description: Anscare Scar Reduction Silicone Gel C+ helps prevent and treat both existing and new scars like keloids and hypertrophic scars resulting from surgery, trauma, burns, etc. (External Use Only)

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):	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
MDA	Elastomer, Silicone, For Scar Management

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: 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
No Device Sizes

Device Record Status

Public Device Record Key: 01b76724-f1a9-4815-902d-cc4fe3958f1a
Public Version Date: February 16, 2024
Public Version Number: 2
DI Record Publish Date: September 19, 2022