Identity
- Trade Name
- Ziplyft Device FDA UDI
- Generic Name
- Ophthalmic knife, single-use FDA UDI
- Device Name
- Non-Sterile Packaged Ziplyft Device EVT2.6, Left FDA UDI
- Model / Reference
- PKG-90-OSH-110001 FDA UDI
- Description
- Non-Sterile Packaged Ziplyft Device EVT2.6, Left FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860011170631 FDA UDI
- FDA Product Code
- HNN FDA UDI
- GMDN Term
- Ophthalmic knife, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Hydrogen Peroxide FDA UDI
Ziplyft Device by Osheru, L.L.C. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Osheru, L.L.C.
Sources (1)
- FDA UDI d1c920fe-804e-4d0a-b021-2bd4503b2880 34 fields · synced Jun 8, 2026