Identity
- Trade Name
- Screw Tray Scaphoid EUDAMEDAPTUS FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- Container EUDAMEDScrew Tray Scaphoid FDA UDI
- Model / Reference
- A-6604.921 EUDAMEDFDA UDI
- Description
- Screw Tray Scaphoid FDA UDI
Identifiers
- Catalog Number
- A-6604.921 FDA UDI
- Primary DI / UDI-DI
- 07630894811722 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378000NY EUDAMED
- 510(k) Number
- K234062 FDA UDI
- FDA Product Code
- HRS 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
- 888.3030 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
K234062 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 f9261ed3-6390-484d-bd03-517ab058a037 35 fields · synced Jun 19, 2026
- EUDAMED c4a2175f-7d4e-4c00-b56e-5d1665c9b73e 61 fields · synced Jun 19, 2026