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Storz Oh\phthalmic Instruments
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref E7411Ref E7407Ref E7409Ref E7406
Identity
- Trade Name
- Storz Ophthalmic Instruments EUDAMEDFDA UDIStorz Oh\phthalmic Instruments FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- SteriBest Instrument Tray EUDAMEDSTERILIZATION TRAY 4” X 6.5” FDA UDISTERILIZATION TRAY 6” X 10” X 1.5” DBL FDA UDISTERILIZATION TRAY 2” X 6” TWO KNIVES FDA UDISTERILIZATION TRAY 6” X 10” FDA UDI
- Model / Reference
- E7411 EUDAMEDE7407 EUDAMEDE7409 EUDAMEDE7406 EUDAMEDCP634-SB FDA UDICP1038D2-SB FDA UDICP614-DK-2 FDA UDICP1038S-SB FDA UDI
- Description
- STERILIZATION TRAY 4” X 6.5” FDA UDISTERILIZATION TRAY 6” X 10” X 1.5” DBL FDA UDISTERILIZATION TRAY 2” X 6” TWO KNIVES FDA UDISTERILIZATION TRAY 6” X 10” FDA UDI
Identifiers
- Catalog Number
- E7409 FDA UDIE7411 FDA UDIE7407 FDA UDIE7406 FDA UDI
- Primary DI / UDI-DI
- 00642356001340 EUDAMEDFDA UDI00642356001357 EUDAMEDFDA UDI00642356001333 EUDAMEDFDA UDI00642356001326 EUDAMEDFDA UDI
- Basic UDI-DI
- 0642356CPTRYJ EUDAMED
- Direct Marketing DI
- 00642356001357 EUDAMED00642356001333 EUDAMED00642356001340 EUDAMED00642356001326 EUDAMED
- FDA Product Code
- LRP 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
- Italy 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
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
Category: Device sterilization/disinfection container, reusable
Storz Oh\phthalmic Instruments by Mastel Surgical Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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
- Mastel Surgical Inc.
Sources (8)
- FDA UDI 5d4a9c40-ffaa-4d6d-b774-960cf3986850 35 fields · synced Jul 23, 2026
- FDA UDI 80774bbd-cb4b-4cd1-aa09-c97e11552011 35 fields · synced May 30, 2026
- FDA UDI 2a433214-1bc2-48b1-9bf6-62a6fe62e36f 35 fields · synced May 30, 2026
- FDA UDI ef255a5b-b252-4efc-9b99-809cc370d585 35 fields · synced May 30, 2026
- EUDAMED d7556a3f-a041-4588-8f41-b93cb51a6a16 61 fields · synced Jul 9, 2026
- EUDAMED e0351b8c-43fa-4592-85fb-0e528dd7d855 61 fields · synced Jul 16, 2026
- EUDAMED a32f11f1-3fc3-40c7-a115-5c640b0a158f 61 fields · synced Jul 20, 2026
- EUDAMED a2b0a5d9-9b71-4337-a3e6-6655658a6de3 61 fields · synced Jul 23, 2026