Khaimi Concentrator, 0.35 mL

GUDID 00840096203691

KATALYST SURGICAL LLC

Ophthalmic working-channel cannula, reusable
Primary Device ID00840096203691
NIH Device Record Keya87a725b-46b7-4150-a092-6e1a7f31eee0
Commercial Distribution StatusIn Commercial Distribution
Brand NameKhaimi Concentrator, 0.35 mL
Version Model Number9001-35
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840096203691 [Primary]

FDA Product Code

HBQInstrument, Clip Removal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840096203691]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-10
Device Publish Date2019-07-02

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