Norlase ECHO photocoagulator

GUDID 05700002165435

The Norlase ECHO Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty

Norlase ApS

Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface Slit lamp/laser system control interface
Primary Device ID05700002165435
NIH Device Record Key4000d6dc-5a45-436e-85ab-f9b76626f4d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameNorlase ECHO photocoagulator
Version Model NumberN007-9200
Company DUNS305483903
Company NameNorlase ApS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS105700002165435 [Primary]

FDA Product Code

HQFLaser, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-23
Device Publish Date2022-11-15

On-Brand Devices [Norlase ECHO photocoagulator]

05700002165435The Norlase ECHO Photocoagulator is intended to be used in ophthalmic laser procedures including
05700002165459The Norlase ECHO Photocoagulator is intended to be used in ophthalmic laser procedures including

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