Identity
- Trade Name
- INSTRUSAFE FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Model / Reference
- CS-1012 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00385640035200 FDA UDI
- 510(k) Number
- K180528 FDA UDI
- FDA Product Code
- KCT FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Device sterilization/disinfection container, reusable
Instrusafe by Summit Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K180528 also covers:
- INSTRUSAFE — Summit Medical, LLC
- INSTRUSAFE — Summit Medical, LLC
- INSTRUSAFE — Summit Medical, LLC
- INSTRUSAFE — Summit Medical, LLC
- INSTRUSAFE — Summit Medical, LLC
- INSTRUSAFE — Summit Medical, LLC
- INSTRUSAFE — Summit Medical, LLC
- INSTRUSAFE — Summit Medical, LLC
- INSTRUSAFE — Summit Medical, LLC
- INSTRUSAFE — Summit Medical, LLC
- INSTRUSAFE — Summit Medical, LLC
- INSTRUSAFE — Summit Medical, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Summit Medical, LLC
Sources (1)
- FDA UDI 4d55fbbe-2c41-4f1d-b35f-9b8ce42d8266 33 fields · synced Jun 1, 2026