Identity
- Trade Name
- Pretzelflex - Surgical Retraction System FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- 3mm Sterilisation Sleeve FDA UDI
- Model / Reference
- SHR7331 FDA UDI
- Description
- 3mm Sterilisation Sleeve FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051986009759 FDA UDI
- 510(k) Number
- K123110 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Pretzelflex - Surgical Retraction System by Surgical Innovations Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K123110 also covers:
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
- Surgical Innovations Limited
Sources (1)
- FDA UDI c9613314-f4b8-4a44-b6df-ad57ac74966c 35 fields · synced Jun 6, 2026