Identity
- Trade Name
- InstruSafe EUDAMEDFDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- InstruSafe Instrument Protection System - Trays, Accessories, and Transport Containers EUDAMED
- Model / Reference
- IN-2020-1550 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00385640025713 EUDAMEDFDA UDI
- Basic UDI-DI
- 03856490146_INSTRUSAJP EUDAMED
- Direct Marketing DI
- 00385640025713 EUDAMED
- 510(k) Number
- K051157 FDA UDIK133015 FDA UDIK140289 FDA UDIK141513 FDA UDIK142630 FDA UDIK142768 FDA UDIK150540 FDA UDIK151166 FDA UDI
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- V0402 CLINICAL USE TRAYS AND BOWLS EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
InstruSafe by Summit Medical, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 03856490146_INSTRUSAJP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Summit Medical, LLC
- EUDAMED SRN
- US-MF-000026771
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED f4b8a75c-07b3-4e38-a62e-14cabc3e53f8 61 fields · synced Jun 8, 2026
- FDA UDI e1b5a073-41fc-4190-add0-95b119aa9dfb 33 fields · synced May 30, 2026