Ziplyft Device

GUDID 00860011170617

Osheru, L.L.C.

Ophthalmic knife, single-use
Primary Device ID00860011170617
NIH Device Record Keyd73baabc-e4de-43f7-97e2-67881edc409b
Commercial Distribution StatusIn Commercial Distribution
Brand NameZiplyft Device
Version Model NumberPKG-90-OSH-100001
Company DUNS094081018
Company NameOsheru, L.L.C.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860011170617 [Primary]

FDA Product Code

HNNKnife, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00860011170617]

Hydrogen Peroxide


[00860011170617]

Hydrogen Peroxide


[00860011170617]

Hydrogen Peroxide


[00860011170617]

Hydrogen Peroxide


[00860011170617]

Hydrogen Peroxide


[00860011170617]

Hydrogen Peroxide


[00860011170617]

Hydrogen Peroxide


[00860011170617]

Hydrogen Peroxide


[00860011170617]

Hydrogen Peroxide


[00860011170617]

Hydrogen Peroxide


[00860011170617]

Hydrogen Peroxide


[00860011170617]

Hydrogen Peroxide


[00860011170617]

Hydrogen Peroxide


[00860011170617]

Hydrogen Peroxide


[00860011170617]

Hydrogen Peroxide


[00860011170617]

Hydrogen Peroxide


[00860011170617]

Hydrogen Peroxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-19
Device Publish Date2024-03-11

On-Brand Devices [Ziplyft Device]

00860011170600Non-Sterile Packaged Ziplyft Device
00860011170624PKG-90-OSH-100002
00860011170617PKG-90-OSH-100001
00860011170686Non-Sterile Ziplyft Device EVT2.7, Right V3
00860011170679Non-Sterile Ziplyft Device EVT2.7, Left V3
00860011170662Non-Sterile Packaged Ziplyft Device EVT2.6, Right V2
00860011170655Non-Sterile Packaged Ziplyft Device EVT2.6, Left V2
00860011170648Non-Sterile Packaged Ziplyft Device EVT2.6, Right
00860011170631Non-Sterile Packaged Ziplyft Device EVT2.6, Left

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.