Identity
- Trade Name
- 1.2/1.5 Screwdriver Blade, HD4, AO EUDAMEDAPTUS FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Blades (not connected to an active device) EUDAMED1.2/1.5 Screwdriver Blade, HD4, AO FDA UDI
- Model / Reference
- A-2311 EUDAMEDFDA UDI
- Description
- 1.2/1.5 Screwdriver Blade, HD4, AO FDA UDI
Identifiers
- Catalog Number
- A-2311 FDA UDI
- Primary DI / UDI-DI
- 07630037873143 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378011P5 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - 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
Yes
Serial Number
No
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 c4ae8d41-ca6d-49f0-9348-74b2758f4791 34 fields · synced Jun 20, 2026
- EUDAMED 8787388e-9a4a-4b0a-a210-faf72e2d82c4 61 fields · synced Jun 20, 2026