FDA UDI
In Commercial Distribution
🇺🇸 United States
Cimeosil® Scar Management, Gel Sheet
DI: M724GSAC1
·
Model: Areola Circle
·
IMPLANTECH ASSOCIATES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Cimeosil® Scar Management, Gel Sheet
- Primary DI
- M724GSAC1
- Version / Model
- Areola Circle
- Catalog Number
- GS-AC
- Company Name
- IMPLANTECH ASSOCIATES, INC.
- Labeler DUNS
- 784664955
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-27
- Public Version
- 2
- Public Version Date
- 2024-02-16
- Public Version Status
- Update
- Public Device Record Key
- 1898f18b-9a19-4d10-89b7-249633431b07
Device Description
Scar Management, Gel Sheet
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MDA | Elastomer, Silicone, For Scar Management | General, Plastic Surgery | 878.4025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M724GSAC1 | HIBCC |
Customer Contacts
- Phone
- 1-800-733-0833
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K982051 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 16 – 29 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 60 – 85 Degrees Fahrenheit