← Back to catalogue
"sty-0059 Stryker Instrument Tray 3"
EUDAMEDFDA UDIClass I (EU MDR)
Ref 78782002
Identity
- Trade Name
- "STY-0059 STRYKER INSTRUMENT TRAY 3" EUDAMEDStryker FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- TRAY EUDAMEDSTRYKER INSTRUMENT TRAY 2 FDA UDI
- Model / Reference
- 78782002 EUDAMEDFDA UDI
- Description
- STRYKER INSTRUMENT TRAY 2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843059104172 EUDAMEDFDA UDI
- Basic UDI-DI
- 8430591TRAY8B EUDAMED
- Direct Marketing DI
- 00843059104172 EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Spain 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
No
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
"sty-0059 Stryker Instrument Tray 3" by TeDan Surgical Innovations, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Instrument tray, reusable.
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- 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
- 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 | 8430591TRAY8B | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- TeDan Surgical Innovations, Inc.
- EUDAMED SRN
- US-MF-000016933
- Authorised Representative
- TeDan Surgical Innovations B.V. NL-AR-000002696
Sources (2)
- EUDAMED 553fcd7f-74a7-4eec-bca0-416abca3b554 61 fields · synced Jul 15, 2026
- FDA UDI 18f43e04-4e96-449c-a3bb-967c6b529412 33 fields · synced May 30, 2026