Abraham Iridectomy Laser Lens

GUDID 00630238007290

OCULAR INSTRUMENTS, INC.

Laser lens, ophthalmic, surgical
Primary Device ID00630238007290
NIH Device Record Keyb367e505-9e15-4826-bc09-e1806b2e52c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAbraham Iridectomy Laser Lens
Version Model NumberOAIY
Company DUNS046212387
Company NameOCULAR INSTRUMENTS, 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 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
GS100630238007290 [Primary]
GS100630238020022 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HJKLens, Contact, Polymethylmethacrylate, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00630238007290]

High-level Disinfectant


[00630238007290]

High-level Disinfectant


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-09-24
Device Publish Date2016-12-12

On-Brand Devices [Abraham Iridectomy Laser Lens]

00630238007290OAIY
00630238007016OAIA

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