Identity
- Trade Name
- SURGISTAR FDA UDI
- Generic Name
- Ophthalmic sponge FDA UDI
- Model / Reference
- Eye Spear EUDAMED504090 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 20878799008156 EUDAMED00878799008152 FDA UDI
- Basic UDI-DI
- 087879900PVASPEARRQ EUDAMED
- FDA Product Code
- HOZ FDA UDI
- EMDN Code
- M0202030101 NON-WOVEN GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE 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
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
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
504090 by Surgistar Inc. — 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 | 087879900PVASPEARRQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Surgistar Inc.
- EUDAMED SRN
- US-MF-000003747
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED dfc42001-c7a5-40cb-9b97-29e9eaf1ecda 61 fields · synced Jul 22, 2026
- FDA UDI b7db18e3-5bca-43fc-bfcd-f04eb1e4972d 33 fields · synced May 30, 2026