Identity
- Trade Name
- TC-100 FDA UDI
- Generic Name
- Implantable bone washer FDA UDI
- Device Name
- WASHER 13.0MM OD FDA UDI
- Model / Reference
- 71143013 FDA UDI
- Description
- WASHER 13.0MM OD FDA UDI
Identifiers
- Catalog Number
- 71143013 FDA UDI
- Primary DI / UDI-DI
- 03596010178060 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
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
Yes
FDA UDI
Manufacturing Date
No
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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Also classified as Implantable bone washer.
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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.
- 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.
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 dd771e09-e4fd-4921-b2a1-ec2d39b5d6f9 36 fields · synced Jun 8, 2026