HRT3

GUDID 04059237000334

Heidelberg Engineering GmbH

Ophthalmic slit lamp, examination
Primary Device ID04059237000334
NIH Device Record Keyca722be9-eee6-4419-bec6-11bda00d90a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameHRT3
Version Model NumberRostock Cornea Module SW V1.5a
Company DUNS329833875
Company NameHeidelberg Engineering GmbH
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 Batchfalse
Serial Numberfalse
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
GS104059237000334 [Primary]

FDA Product Code

MXKDevice,Analysis,Anterior Segment

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-07-14

On-Brand Devices [HRT3 ]

04059237000334Rostock Cornea Module SW V1.5a
04059237000273Rostock Cornea Module SW V1.5
04059237000266HRT3 RCM
04059237000730HRT3 RCM

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