Identity
- Trade Name
- Osteotec Silicone Finger - All In One Silicone Finger Tray, empty FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Osteotec SFI Tray EUDAMEDInstrument Tray for the Osteotec Silicone Finger Instruments FDA UDI
- Model / Reference
- OSTF-INS8 EUDAMEDFDA UDI
- Description
- Instrument Tray for the Osteotec Silicone Finger Instruments FDA UDI
Identifiers
- Catalog Number
- OSTF-INS8 FDA UDI
- Primary DI / UDI-DI
- 05060183095571 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060183090065Y EUDAMED
- Direct Marketing DI
- 05060183095571 EUDAMED
- FDA Product Code
- OJH 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 EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Ireland 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
Osteotec SFI Tray by Osteotec Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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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 | 5060183090065Y | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Osteotec Limited
- EUDAMED SRN
- GB-MF-000019832
- Authorised Representative
- Osteotec Ireland Limited IE-AR-000037895
Sources (2)
- EUDAMED fb4c09ea-30ae-4137-b9e6-738bf31c6e74 61 fields · synced Jun 19, 2026
- FDA UDI 923850db-f81f-44a7-8a0e-4ec13f6d89f5 34 fields · synced May 27, 2026