Identity
- Trade Name
- Silicone Sheeting FDA UDI
- Generic Name
- Silicone-sheet tissue reconstructive material FDA UDI
- Model / Reference
- SP-65000 FDA UDI
Identifiers
- Catalog Number
- SP-65000 FDA UDI
- Primary DI / UDI-DI
- 00385640000109 FDA UDI
- FDA Product Code
- MDA FDA UDI
- GMDN Term
- Silicone-sheet tissue reconstructive material FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4025 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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: Silicone-sheet tissue reconstructive material
Silicone Sheeting by Summit Medical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Silicone-sheet tissue reconstructive material.
- Silicone Sheeting Open Border — Bentec Medical OpCo, LLC. · Class II
- Silicone Sheeting Reinforced — Bentec Medical OpCo, LLC. · Class II
- Silicone Sheeting Open Border — Bentec Medical OpCo, LLC. · Class II
- Silicone Sheeting Reinforced — Bentec Medical OpCo, LLC. · Class II
- Silicone Sheeting Open Border — Bentec Medical OpCo, LLC. · Class II
- Silicone Sheeting Non-Reinforced — Bentec Medical OpCo, LLC. · Class II
- Silicone Sheeting Non-Reinforced — Bentec Medical OpCo, LLC. · Class II
- Silicone Sheeting Non-Reinforced — Bentec Medical OpCo, LLC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Summit Medical, LLC
Sources (1)
- FDA UDI 25c57451-4dc7-4bdf-8b6c-3b6ff25d6f32 34 fields · synced Jun 7, 2026