Identity
- Trade Name
- K-Wire Dispenser "Ø0.8", 185mm EUDAMEDAPTUS FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- Container EUDAMEDK-Wire Dispenser "Ø0.8", 185mm FDA UDI
- Model / Reference
- A-6010.08 EUDAMEDFDA UDI
- Description
- K-Wire Dispenser "Ø0.8", 185mm FDA UDI
Identifiers
- Catalog Number
- A-6010.08 FDA UDI
- Primary DI / UDI-DI
- 07630894811296 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378000NY EUDAMED
- 510(k) Number
- K232251 FDA UDI
- FDA Product Code
- HWC FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
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
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Device sterilization/disinfection container, reusable
Aptus by Medartis Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K232251 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medartis Inc.
Sources (2)
- FDA UDI d1d45484-4c18-4f78-8c8d-a30987cd1dd3 35 fields · synced Jul 13, 2026
- EUDAMED f8113c00-f7e2-4b8e-be9d-75603c674c6e 61 fields · synced Jul 13, 2026