Identity
- Trade Name
- Sterilization Case, Outer FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- Reusable instrument storage case that is used to contain the reusable instruments during sterilization processing in preparation for pelvic fixation procedure. FDA UDI
- Model / Reference
- CIC-003 FDA UDI
- Description
- Reusable instrument storage case that is used to contain the reusable instruments during sterilization processing in preparation for pelvic fixation procedure. FDA UDI
Identifiers
- Catalog Number
- CIC-003 FDA UDI
- Primary DI / UDI-DI
- 10855068008539 FDA UDI
- 510(k) Number
- K180050 FDA UDI
- FDA Product Code
- HSB FDA UDIHWC FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI888.3040 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Device sterilization/disinfection container, reusable
Sterilization Case, Outer by Curvafix Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Device sterilization/disinfection container, reusable.
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Cleared under the same submission
K180050 also covers:
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- Inserter/Extractor — Curvafix Inc
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Curvafix Inc
Sources (1)
- FDA UDI 4863f072-44e9-4a78-9999-38c6b8d807fe 36 fields · synced May 30, 2026