Disposable Iris Retractor Hooks

GUDID 00817489026267

Disposable Iris Retractor Hooks

KATALYST SURGICAL LLC

Intraocular retractor, single-use
Primary Device ID00817489026267
NIH Device Record Key14abda6b-66b8-46cf-af71-52aeb566e5ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Iris Retractor Hooks
Version Model NumberD4176-5
Company DUNS007883297
Company NameKATALYST SURGICAL LLC
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817489026267 [Primary]
GS110817489026264 [Package]
Package: Pack of Hooks [5 Units]
In Commercial Distribution
GS120817489026261 [Package]
Package: Pack of Hooks [2 Units]
In Commercial Distribution

FDA Product Code

HNIRetractor, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-06
Device Publish Date2025-04-28

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