Identity
- Trade Name
- 23GA ACTU8 Talon ILM EUDAMEDVortex Surgical Inc. FDA UDI
- Generic Name
- Ophthalmic soft-tissue manipulation forceps, probe-like, single-use FDA UDI
- Device Name
- Forceps Devices EUDAMED23ga ACTU8 Talon ILM Forceps FDA UDI
- Model / Reference
- VS0752.23 EUDAMEDFDA UDI
- Description
- 23ga ACTU8 Talon ILM Forceps FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810123481842 EUDAMEDFDA UDI
- Basic UDI-DI
- 081012348Forceps9G EUDAMED
- Unit of Use DI
- 00810123481828 EUDAMED
- FDA Product Code
- HNR FDA UDI
- EMDN Code
- Q021102 OPHTHALMIC SURGERY FORCEPS, SINGLE-USE EUDAMED
- GMDN Term
- Ophthalmic soft-tissue manipulation forceps, probe-like, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
23GA ACTU8 Talon ILM by Vortex Surgical, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081012348Forceps9G | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Vortex Surgical Inc
- EUDAMED SRN
- US-MF-000022888
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED b826dc1d-a9a1-4340-8e5d-d3357c158c28 61 fields · synced Jul 20, 2026
- FDA UDI 1ec4d6a4-a864-4a74-926e-4b9bc305be42 33 fields · synced May 30, 2026