Aptimax Instrument TRAY for ULTRA GI Cycle
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- APTIMAX™ Instrument Tray for ULTRA GI™ Cycle EUDAMEDAptimax Instrument TRAY for ULTRA GI Cycle FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- APTIMAX™ Instrument Tray for ULTRA GI™ Cycle EUDAMEDInstrument Tray, Reusable FDA UDI
- Model / Reference
- 011077 EUDAMEDFDA UDI
- Description
- Instrument Tray, Reusable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10705037067190 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705037A170000000000017T8 EUDAMED
- 510(k) Number
- K234082 FDA UDI
- FDA Product Code
- FRG FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Market of Registration
- Netherlands 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
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Instrument tray, reusable
Aptimax Instrument TRAY for ULTRA GI Cycle by Advanced Sterilization Products Services Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Instrument tray, reusable.
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Cleared under the same submission
K234082 also covers:
- STERRAD 100NX with ALLCLEAR Technology And ULTRA GI cyle — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- STERRAD 100NX with ALLCLEAR Technology And ULTRA GI cyle — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Sterrad — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- ULTRA GI Cycle Validation Kit — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Sterilization Products Services Inc.
Sources (2)
- FDA UDI 4a04898f-6ad0-4bd9-922e-a1a1232592f9 36 fields · synced Jun 18, 2026
- EUDAMED 4a0d4266-3ce5-450c-a2ec-5cfd71e71ed8 61 fields · synced Jun 18, 2026