Amoils Epithelial Scrubber AM1EX-HXLx

GUDID 00628693343053

Amoils Epithelial Scrubber - Hyperopic XL Pack of 25

Innova Medical Ophthalmics Inc

Corneal bur system, battery-powered Corneal bur system, battery-powered Corneal bur system, battery-powered Corneal bur system, battery-powered Corneal bur system, battery-powered Corneal bur system, battery-powered Corneal bur system, battery-powered Corneal bur system, battery-powered Corneal bur system, battery-powered Corneal bur system, battery-powered Corneal bur system, battery-powered Corneal bur system, battery-powered
Primary Device ID00628693343053
NIH Device Record Key116aa6d3-f3bc-407a-a96e-b2b7f404094c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmoils Epithelial Scrubber
Version Model NumberHyperopic XL Pack of 25
Catalog NumberAM1EX-HXLx
Company DUNS249464702
Company NameInnova Medical Ophthalmics Inc
Device Count25
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 Datetrue
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
GS100628693343022 [Unit of Use]
GS100628693343053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HOGBurr, Corneal, Battery-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-09
Device Publish Date2022-12-01

On-Brand Devices [Amoils Epithelial Scrubber ]

00628693343053Amoils Epithelial Scrubber - Hyperopic XL Pack of 25
00628693343046Amoils Epithelial Scrubber - Hyperopic Pack of 25
00628693343039Amoils Epithelial Scrubber - Myopic Pack of 25

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