Identity
- Trade Name
- Accord FDA UDI
- Generic Name
- Internal orthopaedic fixation system, cerclage wire/cable, non-sterile FDA UDI
- Device Name
- CABLE PASSER - SMALL FDA UDI
- Model / Reference
- E0016334-1 FDA UDI
- Description
- CABLE PASSER - SMALL FDA UDI
Identifiers
- Catalog Number
- E0016334-1 FDA UDI
- Primary DI / UDI-DI
- 00885556738573 FDA UDI
- FDA Product Code
- HWQ FDA UDI
- GMDN Term
- Internal orthopaedic fixation system, cerclage wire/cable, non-sterile FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Internal orthopaedic fixation system, cerclage wire/cable, non-sterile
Accord by Smith & Nephew, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Internal orthopaedic fixation system, cerclage wire/cable, non-sterile.
- Kirschner wire — Zimmer, Inc. · Class I
- Kirschner wire with trocar tip — Zimmer, Inc. · Class II
- Kirschner wire — Zimmer, Inc. · Class I
- Cerclage Button 3.5T — Miami Device Solutions · Class II
- Cerclage Locking Driver, AO, 2.7T — Miami Device Solutions · Class II
- Single Slot Cerclage Locking Driver, AO, 3.5T — Miami Device Solutions · Class II
- Kirschner wire — Zimmer, Inc. · Class II
- Extractor for trial humeral stem — Zimmer, Inc. · 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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 9129c5df-0b7d-4447-b4fe-d509a535a7d1 35 fields · synced Jun 8, 2026