KAMRA inlay

GUDID 00813359020007

Carton Assembly, ACI 7000

ACUFOCUS, INC.

Corneal inlay, aperture reducing Corneal inlay, aperture reducing Corneal inlay, aperture reducing
Primary Device ID00813359020007
NIH Device Record Keyc822d2ab-f91c-49d7-a654-e7006a803b42
Commercial Distribution StatusIn Commercial Distribution
Brand NameKAMRA inlay
Version Model Number76043
Company DUNS138585281
Company NameACUFOCUS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100813359020007 [Primary]

FDA Product Code

LQEImplant, Corneal, Refractive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-04-29

On-Brand Devices [KAMRA inlay]

00813359020052Carton Assy, US, KAMRA Pod, Dispenser Carton Assembly
00813359020045Carton Assy, US, KAMRA Pod, Unit Carton Assembly
00813359020007Carton Assembly, ACI 7000

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