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CyclaPlex Correction System Instruments Case
FDA UDIClass II (US FDA UDI)
by Alphamet Ltd
Identity
- Trade Name
- CyclaPlex Correction System Instruments Case FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- The anodized aluminum Instruments Case is intended to accommodate the CyclaPlex surgery instruments in the right position for sterilization , surgery procedure and storage. FDA UDI
- Model / Reference
- V7 FDA UDI
- Description
- The anodized aluminum Instruments Case is intended to accommodate the CyclaPlex surgery instruments in the right position for sterilization , surgery procedure and storage. FDA UDI
Identifiers
- Catalog Number
- IC-9801 FDA UDI
- Primary DI / UDI-DI
- 07290017626116 FDA UDI
- 510(k) Number
- K183094 FDA UDI
- FDA Product Code
- HTN FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
Yes
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
CyclaPlex Correction System Instruments Case by Alphamet Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Alphamet Ltd
Sources (1)
- FDA UDI 59a63480-2318-4de5-b0da-602e3d5014f3 36 fields · synced May 31, 2026