Identity
- Trade Name
- Cannulated Compression Headless Screw FDA UDI
- Generic Name
- Orthopaedic guidewire, single-use FDA UDI
- Device Name
- 1.4MM GUIDE WIRE/ 150MM LENGTH TROCAR TIP/ 1PK – STER FDA UDI
- Model / Reference
- 03.333.002.01S FDA UDI
- Description
- 1.4MM GUIDE WIRE/ 150MM LENGTH TROCAR TIP/ 1PK – STER FDA UDI
Identifiers
- Catalog Number
- 03.333.002.01S FDA UDI
- Primary DI / UDI-DI
- 00196449008919 FDA UDI
- 510(k) Number
- K133842 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic guidewire, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Orthopaedic guidewire, single-use
Cannulated Compression Headless Screw by Tyber Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic guidewire, single-use.
- OrthoPediatrics PediFoot Deformity Correction System — ORTHOPEDIATRICS CORP. · Class II
- Gen II Cannulated Screws — ORTHOPEDIATRICS CORP. · Class II
- Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
- 2.7mm Guidewire, Drill Tip, 300mm — OsteoCentric Technologies,Inc · Class I
- Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
- Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
- Ball Tip Wire — Orthopedic Designs North America, Inc. · Class I
- HINGE PEDIATRIC PLATING SYSTEM — Orthopediatrics Canada ULC · Class I
Cleared under the same submission
K133842 also covers:
- Cannulated Compression Headless Screw — Tyber Medical
- Cannulated Compression Headless Screw — Tyber Medical
- Cannulated Compression Headless Screw — Tyber Medical
- Headless Screw System — Tyber Medical
- Headless Screw System — Tyber Medical
- Headless Screw System — Tyber Medical
- Headless Screw System — Tyber Medical
- Tyber Medical — Tyber Medical
- Tyber Medical — Tyber Medical
- Tyber Medical — Tyber Medical
- Tyber Medical — Tyber Medical
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
- Tyber Medical
Sources (1)
- FDA UDI 568e0fbf-1699-46f5-8657-01d98c064307 36 fields · synced May 31, 2026