Identity
- Trade Name
- Orion Headed Screw System Instruments FDA UDI
- Generic Name
- Surgical countersink, reusable FDA UDI
- Device Name
- 2.5 / 3.0 Screw Countersink FDA UDI
- Model / Reference
- HTR-04-009140 FDA UDI
- Description
- 2.5 / 3.0 Screw Countersink FDA UDI
Identifiers
- Catalog Number
- HTR-04-009140 FDA UDI
- Primary DI / UDI-DI
- M695HTR040091400 FDA UDI
- FDA Product Code
- HWW FDA UDI
- GMDN Term
- Surgical countersink, reusable 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Surgical countersink, reusable
Orion Headed Screw System Instruments by Tyber Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical countersink, reusable.
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- Zimmer Cannulated Screw System — Pioneer Surgical Technology, Inc. · Class I
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- COUNTERSINK SMALL FRAG — Biomet Orthopedics, Inc. · Class I
- Cortical Counter Sink — I.T.S. GmbH · Class I
- EVOS — Smith & Nephew, Inc. · Class I
- PERLA ® — Spineart · Class II
- DART-FIRE — WRIGHT MEDICAL TECHNOLOGY, INC. · 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 06c5db8c-26a4-4791-a6ad-28d1d9491062 35 fields · synced May 30, 2026