AccessGUDID - DEVICE: SCAR AID (00850014883188)

GUDID

Device Identifier (DI) Information

Brand Name: SCAR AID
Version or Model: SCST17-US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SCST17-US
Company Name: Biodermis LLC

Primary DI Number: 00850014883188
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809650005 *Terms of Use

Device Description: SCAR AID SILICONE STICK 17g

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	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?
44898	Scar-management dressing, reusable	A covering 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 an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device.	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 [?]
K992146	000

Device Exempt from Premarket Submission: No 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: ba9ad4cf-5fb5-44a6-a759-028393e5f9c1
Public Version Date: March 04, 2025
Public Version Number: 3
DI Record Publish Date: March 10, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: Yes CLOSE

Customer Contact

[?]

Phone: 702-260-4466
Email: customerservice@scaraid.com

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