Procedure Pack Z8
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Procedure Pack for Cataract Surgery SLIM 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 for Cataract Surgery SLIM FDA UDI
- Model / Reference
- Procedure Pack for Corneal Surgery 8.5 mm EUDAMED510.700.119 EUDAMEDCataract L2 FDA UDI
- Description
- Procedure Pack for Cataract Surgery SLIM FDA UDI
Identifiers
- Catalog Number
- 510.700.119 FDA UDI
- Primary DI / UDI-DI
- 07640167751334 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
- Germany 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
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Procedure Pack Z8 by Sie Ltd Surgical Instrument Engineering — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K150323 also covers:
- Procedure Pack Z8 — Sie Ltd Surgical Instrument Engineering
- Procedure Pack Z8 — Sie Ltd Surgical Instrument Engineering
- Procedure Pack Z8 — Sie Ltd Surgical Instrument Engineering
- Procedure Pack Z8 — Sie Ltd Surgical Instrument Engineering
- Procedure Pack Z8 — Sie Ltd Surgical Instrument Engineering
- Procedure Pack Z8 — Sie Ltd Surgical Instrument Engineering
- Procedure Pack Z8 — Sie Ltd Surgical Instrument Engineering
- Procedure Pack Z8 — Sie Ltd Surgical Instrument Engineering
- Procedure Pack Z8 — Sie Ltd Surgical Instrument Engineering
- Procedure Pack Z8 — Sie Ltd Surgical Instrument Engineering
- Procedure Pack Z8 — Sie Ltd Surgical Instrument Engineering
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sie Ltd Surgical Instrument Engineering
Sources (2)
- FDA UDI 2d3359f9-3aff-4d05-a486-4c687a649ef1 36 fields · synced Jun 18, 2026
- EUDAMED 3c41c9c6-ec0f-4c1e-95a8-92e6f860b5ea 61 fields · synced Jun 18, 2026