Identity
- Trade Name
- Ratcheting Handle w/ Quick Connector, AO EUDAMEDAPTUS FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Handles EUDAMEDHandle with Quick Connector, Dental FDA UDI
- Model / Reference
- A-2079 EUDAMEDA-2071 FDA UDI
- Description
- Handle with Quick Connector, Dental FDA UDI
Identifiers
- Catalog Number
- A-2071 FDA UDI
- Primary DI / UDI-DI
- 07630894821189 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378003P6 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- General internal orthopaedic fixation system implantation kit 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: General internal orthopaedic fixation system implantation kit
Aptus by Medartis Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Medartis Inc.
Sources (2)
- FDA UDI 6b0e20a0-b5b7-4ce4-8a07-2174f0dc4e23 34 fields · synced Oct 6, 2026
- EUDAMED fbc49b7f-8cd6-44f2-a5f3-9bb1868b6b36 61 fields · synced Jul 14, 2026