Identity
- Trade Name
- Areza Medical FDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
- Device Name
- Areza Silicone Gel Sheet for Scars is a thin, soft, semi-occlusive, self-adhesive silicone gel sheet made entirely from medical grade silicone. They are effective for the management of both existing and new, hypertrophic or keloid scars. Areza Silicone Gel Sheet for Scars may also be used as a prophylactic treatment on closed wounds to prevent hypertrophic or keloid scarring. Not intended to be used on open, unhealed wounds. FDA UDI
- Model / Reference
- SG4X43 FDA UDI
- Description
- Areza Silicone Gel Sheet for Scars is a thin, soft, semi-occlusive, self-adhesive silicone gel sheet made entirely from medical grade silicone. They are effective for the management of both existing and new, hypertrophic or keloid scars. Areza Silicone Gel Sheet for Scars may also be used as a prophylactic treatment on closed wounds to prevent hypertrophic or keloid scarring. Not intended to be used on open, unhealed wounds. FDA UDI
Identifiers
- Catalog Number
- SG4X43 FDA UDI
- Primary DI / UDI-DI
- 00850021481254 FDA UDI
- FDA Product Code
- NAD FDA UDI
- GMDN Term
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wound-nonadherent dressing, absorbent, non-antimicrobial
Areza Medical by Advanced Medical Associates, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Advanced Medical Associates, Llc
Sources (1)
- FDA UDI 4ed75ddc-b30f-4696-8e2b-3f465fa32d84 36 fields · synced Jun 8, 2026