Procedure Pack for Corneal Surgery 8.5mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Procedure Pack for Corneal Surgery 8.5mm EUDAMEDProcedure Pack Z8 FDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- Procedure Pack for Corneal Surgery 8.5 mm EUDAMEDProcedure Pack Corneal Surgery 8.5 FDA UDI
- Model / Reference
- Procedure Pack for Corneal Surgery 8.5 mm EUDAMED510.700.112 EUDAMED8.5 CS Z8 FDA UDI
- Description
- Procedure Pack Corneal Surgery 8.5 FDA UDI
Identifiers
- Catalog Number
- 510.700.112 FDA UDI
- Primary DI / UDI-DI
- 07640167750580 EUDAMEDFDA UDI
- Basic UDI-DI
- 764016775PPACKSKP EUDAMED
- 510(k) Number
- K150323 FDA UDI
- FDA Product Code
- OOE FDA UDI
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4390 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 8.5 Millimeter FDA UDI
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Procedure Pack for Corneal Surgery 8.5mm by SIE AG, Surgical Instrument Engineering — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764016775PPACKSKP | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- SIE AG, Surgical Instrument Engineering
- EUDAMED SRN
- CH-MF-000025018
- Authorised Representative
- Ziemer Ophthalmology (DE) GmbH DE-AR-000005638
Sources (2)
- EUDAMED fec4fc7f-15ec-4df1-99a0-d48a15eaebb9 61 fields · synced Jun 20, 2026
- FDA UDI 92fb2aad-0b8d-43e9-a7e6-83cc93802b1c 37 fields · synced May 25, 2026