Aura
by Kirwan Surgical Products LLC 270 variants
Ref 24-1443EAU, 20-1619AU, 12-1400AU, 24-1434AU, 12-1625AU, 23-1433AU, 24-1432AU, 20-1418EAU, 15-1437AU, 10-5401EAU, 12-1195AU, 24-1454AU, 20-1604AU, 24-1421EAU, 12-1192AU, 21-1427EAU, 20-1414AU, 12-1429AU, 24-1450EAU, 10-2604AU, 21-1414EAU, 21-1445EAU, 24-1422EAU
Active
CE MDD
Valid until
Not listed
FDA recalls
None foundDocuments
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-00841019106761 | Date1 Jun 2022 | StatusActive |
| United States | GUDID listing GUDID | Number00841019106761 | Date15 May 2016 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Aura EUDAMEDKirwan GUDID
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
- Device Name
- Non-Stick Bipolar Coagulation Forceps 8 in. (20.3cm) Insulated Bayonet, 0.7mm tipNon-Stick Irrigating Bipolar Coagulation Forceps 7 7/8 in. (20.0cm) Yasargil Bayonet, Insulated, 0.7mm tipNon-Stick Bipolar Coagulation Forceps 7 1/2 in. (19.1cm) Cushing Bayonet Insulated, 0.7mm tipNon-Stick Bipolar Coagulation Forceps 7 in. (17.8cm) Insulated Bayonet, 1.0mm tipNon-Stick Irrigating Bipolar Coagulation Forceps 8 3/4 in. (22.2cm) Hardy Bayonet, Insulated with stops, 0.25mm tipNon-Stick Bipolar Coagulation Forceps 10 1/2 in. (26.6cm) Yasargil Bayonet, 0.7mm tipNon-Stick Bipolar Coagulation Forceps 7 in. (17.8cm) Insulated Bayonet, 0.5mm tipNon-Stick Bipolar Coagulation Forceps 7 7/8 in. (20.0cm) Insulated Yasargil Bayonet, 0.5mm tipNon-Stick Bipolar Coagulation Forceps 9 3/4 in. (24.8cm) Hardy Bayonet Insulated with stops, 1.0mm tipNon-Stick Bipolar Coagulation Forceps 8 3/4 in. (22.2cm) Insulated Bayonet with stop, 1.5mm tip4 1/4" COAPTATION BIPOLAR FORCEPS EXTRA FINE, 0.4mm TIPNon-Stick Bipolar Coagulation Forceps 8 3/4 in. (22.2cm) Insulated Bayonet, 1.0mm tipNon-Stick Irrigating Bipolar Coagulation Forceps 6 1/4 in. (15.9cm) Insulated Yasargil Bayonet, 0.25mm tipNon-Stick Bipolar Coagulation Forceps 6 1/4 in. (15.9cm) Insulated Bayonet, 0.2mm tipNon-Stick Bipolar Coagulation Forceps 10 1/4 in. (26.0cm) Insulated Yasargil Bayonet, 0.7mm tipNon-Stick Bipolar Coagulation Forceps 7 1/8 in. (18.1cm) Insulated Yasargil Bayonet, 0.5mm tipNon-Stick Bipolar Coagulation Forceps 8 3/4 in. (22.2cm) Hardy Bayonet Insulated with stops, 2.0mm tipNon-Stick Bipolar Coagulation Forceps 8 3/4 in. (22.2cm) Insulated Bayonet, 0.1mm tipNon-Stick Irrigating Bipolar Coagulation Forceps 7 1/2 in. (19.1cm) Cushing Bayonet Insulated, 2.0mm tipNon-Stick Bipolar Coagulation Forceps 7 3/4 in. (19.7cm) Insulated Yasargil Bayonet, 0.4mm tipNon-Stick Bipolar Coagulation Forceps 8 1/2 in. (21.6cm) Insulated Yasargil Bayonet 0.2mm tipNon-Stick Bipolar Coagulation Forceps 6 1/4 in. (15.9cm) Insulated Bayonet, 0.5mm tip
- Model / Reference
- 24-1443EAU, 20-1604AU, 24-1450EAU, 20-1619AU, 24-1432AU, 24-1421EAU, 24-1422EAU, 20-1414AU, 15-1437AU, 12-1400AU, 12-1195AU, 24-1454AU, 24-1434AU, 10-5401EAU, 12-1625AU, 23-1433AU, 12-1192AU, 12-1429AU, 21-1427EAU, 21-1445EAU, 21-1414EAU, 20-1418EAU, 10-2604AU, 20-1618AU, 24-1465EAU, 24-1449EAU, 21-1447AU, 20-1419AU
- Primary DI / UDI-DI
- 00841019106761, 00841019108000, 00841019106808, 00841019105399, 00841019105856, 00841019119310, 00841019119327, 00841019104989, 00841019109595, 00841019103128, 00841019103111, 00841019106013, 00841019105870, 00841019106181, 00841019108352, 00841019105801, 00841019103104, 00841019103135, 00841019106631, 00841019108611, 00841019106501, 00841019106389, 00841019101469, 00841019105382, 00841019106938, 00841019118979, 00841019105719, 00841019105030
- Basic UDI-DI
- B-00841019106761, B-00841019105399, B-00841019103128, B-00841019105870, B-00841019108352, B-00841019105801, B-00841019105856, B-00841019106389, B-00841019109595, B-00841019106181, B-00841019103111, B-00841019106013, B-00841019108000, B-00841019119310, B-00841019103104, B-00841019106631, B-00841019104989, B-00841019103135, B-00841019106808, B-00841019101469, B-00841019106501, B-00841019108611, B-00841019119327
- 510(k) Number
- FDA Product Code
- GEI
- EMDN Code
- L180401 Open electrosurgery forceps, reusable
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
- Device Class
- Class IIb EUDAMEDClass II GUDID
- Regulation Number
- 878.4400
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
- Size
- Length — 6.25 InchLength — 8.75 InchLength — 7.88 InchLength — 7 InchLength — 10 InchLength — 7.13 InchLength — 9.5 InchLength — 7.5 InchLength — 4.25 InchLength — 8 InchLength — 10.25 InchLength — 10.5 InchLength — 4 InchLength — 8.5 InchLength — 7.75 Inch
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIb | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000008222
- Authorised representative
- MPS Medical Product Service GmbH DE-AR-000005009
Other devices from Kirwan Surgical Products LLC
Properties
Other properties (18)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No