GUDID M735B5236035

OPHTHALMED LLC

Ophthalmic laser system beam guide
Primary Device IDM735B5236035
NIH Device Record Keyc88201cc-469d-4aad-95a9-af0e25b9986f
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberB523603
Company DUNS791553436
Company NameOPHTHALMED LLC
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7707776613
Emailinfo@ophthalmed.com
Phone7707776613
Emailinfo@ophthalmed.com
Phone7707776613
Emailinfo@ophthalmed.com
Phone7707776613
Emailinfo@ophthalmed.com
Phone7707776613
Emailinfo@ophthalmed.com
Phone7707776613
Emailinfo@ophthalmed.com
Phone7707776613
Emailinfo@ophthalmed.com
Phone7707776613
Emailinfo@ophthalmed.com
Phone7707776613
Emailinfo@ophthalmed.com
Phone7707776613
Emailinfo@ophthalmed.com
Phone7707776613
Emailinfo@ophthalmed.com
Phone7707776613
Emailinfo@ophthalmed.com
Phone7707776613
Emailinfo@ophthalmed.com
Phone7707776613
Emailinfo@ophthalmed.com
Phone7707776613
Emailinfo@ophthalmed.com

Device Dimensions

Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM735B5236031 [Primary]
HIBCCM735B5236035 [Package]
Contains: M735B5236031
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQFLaser, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-30
Device Publish Date2022-09-22

Devices Manufactured by OPHTHALMED LLC

M735A5026005 - NA2022-09-30
M735A5027005 - NA2022-09-30
M735A5036005 - NA2022-09-30
M735A5037005 - NA2022-09-30
M735A5076005 - NA2022-09-30
M735A5077005 - NA2022-09-30
M735A5086005 - NA2022-09-30
M735A5087005 - NA2022-09-30

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