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Headless Screw System Instruments
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref T001000051
Identity
- Trade Name
- Headless Screw System Instruments FDA UDI
- Generic Name
- Orthopaedic bone pin container FDA UDI
- Device Name
- Instrumentation EUDAMED0.9mm Guidewire Dispenser FDA UDI
- Model / Reference
- T001000051 EUDAMEDFDA UDI
- Description
- 0.9mm Guidewire Dispenser FDA UDI
Identifiers
- Catalog Number
- T001000051 FDA UDI
- Primary DI / UDI-DI
- 00810030824893 EUDAMEDFDA UDI
- Basic UDI-DI
- 081001136002WB EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- P091280 OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES EUDAMED
- GMDN Term
- Orthopaedic bone pin container FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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: Orthopaedic bone pin container
Headless Screw System Instruments by Tyber Medical — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone pin container.
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- K-Wire and Steinmann Pin Dispensers — Key Surgical, LLC · Class I
- Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
- Newclip Instruments — NEWCLIP TECHNICS · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tyber Medical
Sources (2)
- FDA UDI 46c02b7c-4f29-4c0a-9db1-059390d231f6 35 fields · synced Jun 19, 2026
- EUDAMED 221f0c2e-c031-4027-8cf3-9190adb7f568 61 fields · synced Jun 14, 2026