Identity
- Trade Name
- 3mm Pretzelflex Retractor EUDAMEDPretzelflex - Surgical Retraction System FDA UDI
- Generic Name
- Externally-anchored laparoscopic retractor FDA UDI
- Device Name
- 3mm Pretzelflex Retractor EUDAMEDFDA UDIPretzelFlex EUDAMED
- Model / Reference
- SHR7301 EUDAMEDFDA UDI
- Description
- 3mm Pretzelflex Retractor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051986009667 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05051986009667 EUDAMED5051986SIRUP4W EUDAMED
- Direct Marketing DI
- 05051986009667 EUDAMED
- 510(k) Number
- K123110 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- L1206 LAPAROSCOPIC AND THORACOSCOPIC SURGERY SPREADERS AND RETRACTORS, REUSABLE EUDAMED
- GMDN Term
- Externally-anchored laparoscopic retractor FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
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
3mm Pretzelflex Retractor by Surgical Innovations Ltd. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05051986009667 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-05051986009667 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Surgical Innovations Ltd.
- EUDAMED SRN
- GB-MF-000012187
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (3)
- EUDAMED 0ff7d46b-11fb-48f1-8b75-92b36ddea29c 61 fields · synced Jun 19, 2026
- EUDAMED 2c13e15b-c866-4a12-a89e-417b6c6f53af 61 fields · synced May 19, 2026
- FDA UDI 6dc9431b-416e-4cd7-9fc3-fdc41c04fc0b 34 fields · synced May 30, 2026