Identity
- Trade Name
- Technical Products FDA UDI
- Generic Name
- Silicone-block tissue reconstructive material FDA UDI
- Device Name
- silicone thick sheet or block (soft) FDA UDI
- Model / Reference
- 801-S FDA UDI
- Description
- silicone thick sheet or block (soft) FDA UDI
Identifiers
- Primary DI / UDI-DI
- B051801S0 FDA UDI
- 510(k) Number
- K973166 FDA UDI
- FDA Product Code
- MIB FDA UDI
- GMDN Term
- Silicone-block tissue reconstructive material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: Silicone-block tissue reconstructive material
Technical Products by Technical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K973166 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.
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 45e7e0ba-e893-4577-a3c6-1ee869b34d7c 35 fields · synced Jun 8, 2026