AccessGUDID - DEVICE: CicaCare 12cm x 6cm Ctn of 1 Global (05000223441586)

GUDID

Device Identifier (DI) Information

Brand Name: CicaCare 12cm x 6cm Ctn of 1 Global
Version or Model: 66250704
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 66250704 & 66250705
Company Name: SMITH & NEPHEW MEDICAL LIMITED

Primary DI Number: 05000223441586
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 216344051 *Terms of Use

Device Description: Silicone Gel Sheet. Treatment for red and raised, old and new scars

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):	No
Over the Counter (OTC):	No
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 [?]
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: 90e4a968-af06-4573-bdfd-072f10e5a398
Public Version Date: February 16, 2024
Public Version Number: 4
DI Record Publish Date: February 12, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
05000223441784	1	05000223441586	In Commercial Distribution	Carton
05000223441791	20	05000223441784	In Commercial Distribution	Case
05000223441807	40	05000223441784	In Commercial Distribution	Case 66250705