Identity
- Trade Name
- Cannulated Screw Guide Pin FDA UDI
- Generic Name
- Orthopaedic guidewire, single-use FDA UDI
- Device Name
- GDE PIN DRL TIP 2.8X300MM STE FDA UDI
- Model / Reference
- 28ZBGP300 FDA UDI
- Description
- GDE PIN DRL TIP 2.8X300MM STE FDA UDI
Identifiers
- Catalog Number
- 28ZBGP300 FDA UDI
- Primary DI / UDI-DI
- 00810030825036 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic guidewire, single-use 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic guidewire, single-use
Cannulated Screw Guide Pin by Tyber Medical — Class I — 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
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 |
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Manufacturer
- Manufacturer
- Tyber Medical
Sources (1)
- FDA UDI 7bc09404-1023-4d70-a4e4-4d9b3817cfaf 34 fields · synced Jun 8, 2026