← Back to catalogue
Pistol Grip Handle without Ratchet
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 101-43000
Identity
- Trade Name
- Pistol Grip Handle without Ratchet EUDAMEDLogic - Laparoscopic Instrument System FDA UDI
- Generic Name
- Electrocautery system handpiece FDA UDI
- Device Name
- Pistol Grip Handle without Ratchet EUDAMEDFDA UDI
- Model / Reference
- 101-43000 EUDAMED101 - 43000 FDA UDI
- Description
- Pistol Grip Handle without Ratchet FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051986000053 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05051986000053 EUDAMED
- 510(k) Number
- K063485 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L180302 ENDOSCOPIC ELECTROSURGERY HANDPIECES, REUSABLE EUDAMED
- GMDN Term
- Electrocautery system handpiece FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Pistol Grip Handle without Ratchet by Surgical Innovations Ltd. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05051986000053 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Surgical Innovations Ltd.
- EUDAMED SRN
- GB-MF-000012187
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (2)
- EUDAMED 818fcd0f-f488-48d4-b423-881f256bc471 61 fields · synced Aug 1, 2026
- FDA UDI 2b822cf9-2b1b-4d58-8d29-36d58f25959f 34 fields · synced May 30, 2026