Identity
- Trade Name
- TC-100 FDA UDI
- Generic Name
- Implantable bone washer FDA UDI
- Device Name
- 13.0MM O.D. WASHER FDA UDI
- Model / Reference
- 71143113 FDA UDI
- Description
- 13.0MM O.D. WASHER FDA UDI
Identifiers
- Catalog Number
- 71143113 FDA UDI
- Primary DI / UDI-DI
- 23596010381822 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Implantable bone washer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Implantable bone washer
Tc-100 by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K210837 also covers:
- CHS — Smith & Nephew, Inc.
- CHS — Smith & Nephew, Inc.
- D-RAD SMART PACK — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
K213126 also covers:
- CHS — Smith & Nephew, Inc.
- CHS — Smith & Nephew, Inc.
- CHS — Smith & Nephew, Inc.
- CHS — Smith & Nephew, Inc.
- CHS — Smith & Nephew, Inc.
- CHS — Smith & Nephew, Inc.
- CONQUEST FN — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
- EVOS — Smith & Nephew, Inc.
K993106 also covers:
- CHS — Smith & Nephew, Inc.
- LARGE CANNULATED SCREWS — Smith & Nephew, Inc.
- LARGE CANNULATED SCREWS — Smith & Nephew, Inc.
- Peri-Loc — Smith & Nephew, Inc.
- TC-100 — Smith & Nephew, Inc.
- TC-100 — Smith & Nephew, Inc.
- TC-100 — Smith & Nephew, Inc.
- TC-100 — Smith & Nephew, Inc.
- TC-100 — Smith & Nephew, Inc.
- TC-100 — Smith & Nephew, Inc.
- TC-100 — Smith & Nephew, Inc.
- TC-100 — Smith & Nephew, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI cc23516b-3108-4db2-906e-8b79e4b34cc4 36 fields · synced Jun 8, 2026