Identity
- Trade Name
- Instrument Tray APTUS, Lag Screw Clamp EUDAMEDAPTUS FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- Container EUDAMEDInstrument Tray APTUS, Lag Screw Clamp FDA UDI
- Model / Reference
- A-6604.117 EUDAMEDFDA UDI
- Description
- Instrument Tray APTUS, Lag Screw Clamp FDA UDI
Identifiers
- Catalog Number
- A-6604.117 FDA UDI
- Primary DI / UDI-DI
- 07630894817489 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378000NY EUDAMED
- 510(k) Number
- K243610 FDA UDI
- FDA Product Code
- FSM 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 EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
Yes
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 I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K243610 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medartis Inc.
Sources (2)
- FDA UDI a3df6bf5-7d82-4b58-b4f5-0498f8957ddf 35 fields · synced Jun 19, 2026
- EUDAMED 6d476eba-bf84-41b0-8fb3-390715629df5 61 fields · synced Jun 19, 2026