Identity
- Trade Name
- Disassembler FDA UDI
- Generic Name
- Orthopaedic instrument extractor FDA UDI
- Device Name
- WEDGED DISASSEM. IMG THREADED COMP. FDA UDI
- Model / Reference
- Disassembler FDA UDI
- Description
- WEDGED DISASSEM. IMG THREADED COMP. FDA UDI
Identifiers
- Catalog Number
- IZ05901 FDA UDI
- Primary DI / UDI-DI
- 08054752863248 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic instrument extractor 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
No
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 instrument extractor
Disassembler by Adler Ortho Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic instrument extractor.
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- Truliant — Exactech, Inc. · Class I
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- ORTHOMED — ORTHO-MED, INC. · Class I
- Equinoxe — Exactech, Inc. · Class II
- Invictus — ALPHATEC SPINE, INC. · Class I
- Envoy Percutaneous Implant Guide System — SPINEOLOGY 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
- Adler Ortho Spa
Sources (1)
- FDA UDI 2af90a3f-1acd-46c5-87b4-b8f056db06c6 34 fields · synced May 30, 2026