Identity
- Trade Name
- Aptimax™ Instrument Tray 450 mm x 200 mm x 50 mm (18 in x 8 in x 2 in) EUDAMEDAptimax FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- APTIMAX™ Instrument Trays EUDAMEDInstrument Tray 450 mm x 200 mm x 50 mm (18 in x 8 in x 2 in) FDA UDI
- Model / Reference
- 13830 EUDAMEDFDA UDI
- Description
- Instrument Tray 450 mm x 200 mm x 50 mm (18 in x 8 in x 2 in) FDA UDI
Identifiers
- Catalog Number
- 13830 FDA UDI
- Primary DI / UDI-DI
- 10705037016051 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705037A070000000000007RN EUDAMED
- 510(k) Number
- K013003 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Instrument tray, reusable
Aptimax by Advanced Sterilization Products Services Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Instrument tray, reusable.
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- Instrument Case — Katena Products, Inc. · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
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Cleared under the same submission
K013003 also covers:
- 100NX DUO Upgrade Kit with VELOCITY — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Aptimax — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Aptimax — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Aptimax — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Aptimax — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Aptimax — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Aptimax — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Aptimax — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Aptimax — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Aptimax — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Aptimax — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Aptimax — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- Advanced Sterilization Products Services Inc.
Sources (2)
- FDA UDI b054ba85-cc11-4d55-954c-438762d34224 37 fields · synced Jul 9, 2026
- EUDAMED ca095f09-d264-4a9d-833c-7e698095320e 61 fields · synced Jul 9, 2026