Identity
- Trade Name
- CONMED EUDAMEDFDA UDI
- Generic Name
- TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMEDInstrument tray, reusable FDA UDI
- Device Name
- Orthopedic, Non-active, Instrument Tray EUDAMEDKPS Accessories Insert Tray FDA UDI
- Model / Reference
- INST-ACL03 EUDAMEDFDA UDI
- Description
- KPS Accessories Insert Tray FDA UDI
Identifiers
- Catalog Number
- INST-ACL03 FDA UDI
- Primary DI / UDI-DI
- 10845854042793 EUDAMEDFDA UDI
- Basic UDI-DI
- 084585408521D5 EUDAMED
- Direct Marketing DI
- 20845854042790 EUDAMED
- FDA Product Code
- FSM 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 FDA UDI
- Legislation / Framework
- MDR (REGULATION (EU) 2017/745 on medical devices) EUDAMED
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Belgium 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Instrument tray, reusable
Conmed by Conmed Corporation (trays, baskets, tubs for sterilisation and their components) — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Instrument tray, reusable.
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- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
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- ASELTECH — Asel Tibbi Aletler A.S. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 084585408521D5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 68 fields · synced May 31, 2026
- FDA UDI 6aa34af9-2ea3-4a2a-9f28-94a96e3b8d3d 36 fields · synced May 27, 2026