Identity
- Trade Name
- Aura EUDAMEDKirwan FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- Non-Stick Bipolar Coagulation Forceps 7 1/2 in. (19.1cm) Cushing Bayonet Insulated, 0.7mm tip EUDAMEDNon-Stick Bipolar Coagulation Forceps 7 1/2" (19.1cm) Cushing Bayonet Insulated, 0.7mm Tip FDA UDI
- Model / Reference
- 15-1400AU EUDAMEDFDA UDI
- Description
- Non-Stick Bipolar Coagulation Forceps 7 1/2" (19.1cm) Cushing Bayonet Insulated, 0.7mm Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841019104002 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841019104002 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L180401 OPEN ELECTROSURGERY FORCEPS, REUSABLE EUDAMED
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Germany 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
Dimensions & Sizes
- Size
- Length — 7.5 Inch FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, bipolar, reusable
Aura by Kirwan Surgical Products Llc — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-00841019104002 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Kirwan Surgical Products LLC
- EUDAMED SRN
- US-MF-000008222
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (2)
- EUDAMED b444020f-ad6f-4bdd-b6dc-02b6359c503e 61 fields · synced Oct 6, 2026
- FDA UDI 466e99b3-7520-4027-842a-d2ab7885ce14 35 fields · synced May 26, 2026