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Instrument
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 4845-7-600Model 08858250000817SC
Identity
- Trade Name
- Anato EUDAMEDINSTRUMENT FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- TF-018 Class I - Cases/Trays/Bowles EUDAMEDSTRYKER CASE FDA UDI
- Model / Reference
- 4845-7-600 EUDAMEDFDA UDI08858250000817SC EUDAMED
- Description
- STRYKER CASE FDA UDI
Identifiers
- Catalog Number
- 4845-7-600 FDA UDI
- Primary DI / UDI-DI
- 07613327196122 EUDAMEDFDA UDI
- Basic UDI-DI
- 08858250000817SC EUDAMED
- Direct Marketing DI
- 07613327196122 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- V0402 CLINICAL USE TRAYS AND BOWLS EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Instrument tray, reusable
Instrument by Howmedica Osteonics Corp. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Instrument tray, reusable.
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- ASELTECH — Asel Tibbi Aletler A.S. · Class I
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Howmedica Osteonics Corp.
Sources (2)
- FDA UDI d5b133d9-d131-429b-872f-24bc3c16fd34 34 fields · synced Oct 8, 2026
- EUDAMED 397c0c4b-a698-42f5-ae0f-5b0c5103e40c 61 fields · synced Oct 8, 2026