Identity
- Trade Name
- TRIGEN MAX ENTRY REAMER 12.5 MM, JACOB-HALL FDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, flexible FDA UDI
- Device Name
- Flexible Entry reamer is used to prepare the medullary cavity of humeral bone prior to placing a nail. This is a reusable device. FDA UDI
- Model / Reference
- T18772 FDA UDI
- Description
- Flexible Entry reamer is used to prepare the medullary cavity of humeral bone prior to placing a nail. This is a reusable device. FDA UDI
Identifiers
- Catalog Number
- T18772 FDA UDI
- Primary DI / UDI-DI
- 07640187918069 FDA UDI
- FDA Product Code
- HTO FDA UDI
- GMDN Term
- Medullary canal orthopaedic reamer, flexible 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: Medullary canal orthopaedic reamer, flexible
Trigen Max Entry Reamer 12.5 Mm, Jacob-Hall by MPS Micro Precision Systems AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Medullary canal orthopaedic reamer, flexible.
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- Arthrex® — Arthrex, Inc. · Class I
- NITINOL MODULAR REAMER HUDSON — Biomet Orthopedics, Inc. · Class I
- Dyna Locking IM Nail — CG MedTech Co., Ltd. · Class I
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE · 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 |
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Manufacturer
- Manufacturer
- MPS Micro Precision Systems AG
Sources (1)
- FDA UDI 58249ee9-aefc-435d-ab9a-13e8b4805b03 35 fields · synced May 30, 2026