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23ga ACTU8 Pro-Grip Forceps Box of 5
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref VS0743.23Model ACTU8Ref VS0713.23
Identity
- Trade Name
- 23GA ACTU8 Pro-Grip Forceps EUDAMEDVortex Surgical Inc FDA UDI
- Generic Name
- Ophthalmic soft-tissue manipulation forceps, probe-like, single-use FDA UDI
- Device Name
- 23ga ACTU8 Pro-Grip Forceps Box of 5 EUDAMEDFDA UDIForceps Devices EUDAMED
- Model / Reference
- ACTU8 EUDAMEDVS0743.23 EUDAMEDVS0713.23 EUDAMEDFDA UDI
- Description
- 23ga ACTU8 Pro-Grip Forceps Box of 5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810123481507 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810123481507 EUDAMED081012348Forceps9G EUDAMED
- Unit of Use DI
- 00810123481095 EUDAMED
- FDA Product Code
- HNR FDA UDI
- EMDN Code
- Q020599 RETINAL DETACHMENT DEVICES - OTHER EUDAMEDQ021102 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
- Spain EUDAMEDFrance 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 Pro-Grip Forceps Box of 5 by Vortex Surgical, Inc. — 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-00810123481507 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00810123481507 | 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 (3)
- EUDAMED 8b6e0a1c-4d70-4b5d-bc46-243d67a74e0f 61 fields · synced Jun 19, 2026
- EUDAMED a6ed19b2-a564-4422-b41e-e19ab851c3b8 61 fields · synced May 19, 2026
- FDA UDI 3653da1e-05b8-4f54-87f4-cb872d80fb2f 33 fields · synced May 30, 2026