Identity
- Trade Name
- SURGISTAR FDA UDI
- Generic Name
- Manual scalpel blade, single-use FDA UDI
- Model / Reference
- Crescent Knife EUDAMEDLP7510AT EUDAMED960012 FDA UDI
Identifiers
- Catalog Number
- LP7510AT FDA UDI
- Primary DI / UDI-DI
- 00878799004185 EUDAMEDFDA UDI
- Basic UDI-DI
- 087879900CrescentZ2 EUDAMED
- 510(k) Number
- K923689 FDA UDI
- FDA Product Code
- GDX FDA UDI
- EMDN Code
- Q02010102 OPHTHALMIC MICROKNIVES, ANGLED EUDAMED
- GMDN Term
- Manual scalpel blade, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 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
Lp7510at by Surgistar 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 | 087879900CrescentZ2 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 72e367d6-be24-4c64-bce0-cfc6d302fd02 61 fields · synced Jun 18, 2026
- FDA UDI 775c8d16-8ef1-43ff-8654-1c0e6f76cc71 35 fields · synced May 30, 2026