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PVA Wick and Wipe (1mm)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1-421BModel PVA and Cellulose Ophthalmic (Non-sterile, Patient Contacting)
Identity
- Trade Name
- Eyetec FDA UDI
- Generic Name
- Ophthalmic sponge FDA UDI
- Device Name
- PVA Wick and Wipe (1mm) EUDAMED1-421B Corneal Light Shield Bulk Packed Non-sterile 8mm - 500 Glassines Per Bag FDA UDI
- Model / Reference
- PVA and Cellulose Ophthalmic (Non-sterile, Patient Contacting) EUDAMED1-421B EUDAMEDFDA UDI
- Description
- 1-421B Corneal Light Shield Bulk Packed Non-sterile 8mm - 500 Glassines Per Bag FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056100707498 EUDAMEDFDA UDI
- Basic UDI-DI
- 506016501T1_02_PVACELLOSA EUDAMED
- 510(k) Number
- K130117 FDA UDI
- FDA Product Code
- HOZ FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Ophthalmic sponge FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4790 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
PVA Wick and Wipe (1mm) by Network Medical Products Limited — Class I — 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 | 506016501T1_02_PVACELLOSA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Network Medical Products Limited
- EUDAMED SRN
- GB-MF-000025518
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 9eb5404b-6e46-4c85-8456-4c510f8933bb 61 fields · synced Jul 25, 2026
- FDA UDI 4e1dc026-04cc-43c0-9e62-1f795185de25 34 fields · synced May 30, 2026