Identity
- Trade Name
- Vortex Surgical Inc FDA UDI
- Generic Name
- Ophthalmic soft-tissue manipulation forceps, probe-like, single-use FDA UDI
- Device Name
- 27ga ACTU8 Pro-Grip Forceps EUDAMED27ga ACTU8 Pro-Grip Forceps Box of 5 FDA UDI
- Model / Reference
- VS0713.27 EUDAMEDFDA UDI
- Description
- 27ga ACTU8 Pro-Grip Forceps Box of 5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810123481118 EUDAMED00810123481521 FDA UDI
- Basic UDI-DI
- B-00810123481118 EUDAMED
- FDA Product Code
- HNR FDA UDI
- EMDN Code
- Q020599 RETINAL DETACHMENT DEVICES - OTHER 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 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
27ga ACTU8 Pro-Grip Forceps by Vortex Surgical, Inc. — Class IIa — 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-00810123481118 | 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 410fa35b-cb29-4110-8041-90d611772d5a 61 fields · synced Jun 18, 2026
- FDA UDI 220a8248-2b0f-450a-8675-8b5301129413 33 fields · synced May 30, 2026