Identity
- Trade Name
- Technical Products FDA UDI
- Generic Name
- Silicone-sheet tissue reconstructive material FDA UDI
- Device Name
- silicone sheet sterile Reinforced FDA UDI
- Model / Reference
- 501-5S68 FDA UDI
- Description
- silicone sheet sterile Reinforced FDA UDI
Identifiers
- Primary DI / UDI-DI
- B0515015S680 FDA UDI
- 510(k) Number
- K971472 FDA UDI
- FDA Product Code
- FTL FDA UDI
- GMDN Term
- Silicone-sheet tissue reconstructive material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Silicone-sheet tissue reconstructive material
Technical Products by Technical Products, Inc. — Class II — 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 — Summit Medical, LLC · Class I
- 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
Cleared under the same submission
K971472 also covers:
- Technical Products — TECHNICAL PRODUCTS, INC.
- Technical Products — TECHNICAL PRODUCTS, INC.
- Technical Products — TECHNICAL PRODUCTS, INC.
- Technical Products — TECHNICAL PRODUCTS, INC.
- Technical Products — TECHNICAL PRODUCTS, INC.
- Technical Products — TECHNICAL PRODUCTS, INC.
- Technical Products — TECHNICAL PRODUCTS, INC.
- Technical Products — TECHNICAL PRODUCTS, INC.
- Technical Products — TECHNICAL PRODUCTS, INC.
- Technical Products — TECHNICAL PRODUCTS, INC.
- Technical Products — TECHNICAL PRODUCTS, INC.
- Technical Products — TECHNICAL PRODUCTS, INC.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Technical Products, Inc.
Sources (1)
- FDA UDI 64969a97-86ea-4b67-ae44-c22ebf938c43 35 fields · synced May 31, 2026