Model: 66801491
Catalog: 66801491
DI: 05000223482589
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-04-30
Current Version: 2026-05-08
Description
CICA-CARE GEL 15G (Global)
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
29188851-2b48-4537-bb22-ac2f4dff2733
Distribution Status:
In Commercial Distribution
DUNS Number:
216344051
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05000223482589
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47771
Name: Scar-management dressing, single-use
Definition:
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.
FDA Product Codes
MDA
Elastomer, silicone, for scar management
Device Sizes
Item #1 - Size Text:
Size: 15G
Item #1 - Size Type:
Device Size Text, specify
Item #2 - Size - @attributes - Unit:
Gram
Item #2 - Size - @attributes - Value:
105
Item #2 - Size Type:
Weight
Item #3 - Size - @attributes - Unit:
Centimeter
Item #3 - Size - @attributes - Value:
70
Item #3 - Size Type:
Width
Environmental Conditions
Item #1 - Storage Handling Type:
Special Storage Condition, Specify
Item #1 - Storage Handling Special Condition Text:
25C / 77F
Item #2 - Storage Handling Type:
Special Storage Condition, Specify
Item #2 - Storage Handling Special Condition Text:
Keep away from sunlight
Item #3 - Storage Handling Type:
Special Storage Condition, Specify
Item #3 - Storage Handling Special Condition Text:
Keep dry