Device
Silicone Scar Sheets: The silicone scar sheets consists of a backing, silcone gel and an anti-stick layer(removed when using).
Manufacturer
Star Port Inc
Star Port Inc
Model: SC-03
DI: 00860015727305
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-25
Current Version: 2026-05-04
Description
Silicone Scar Sheets: The silicone scar sheets consists of a backing, silcone gel and an anti-stick layer(removed when using).
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
23a645cf-81b9-4a9d-99df-348539e15295
Distribution Status:
In Commercial Distribution
DUNS Number:
119316658
Device Count:
5
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
20860015727309
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00860015727305
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 44898
Name: Scar-management dressing, reusable
Definition:
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.
FDA Product Codes
MDA
Elastomer, Silicone, For Scar Management