K 180 OPHTHALMOSCOPE C-001.30.206

GUDID 04053755120017

since 2024-05 in LED version: K180 LED ophthalmoscope

Heine Optotechnik GmbH & Co. KG

Direct ophthalmoscope
Primary Device ID04053755120017
NIH Device Record Keyca672506-4f87-4c42-bc31-f6507dd87752
Commercial Distribution StatusIn Commercial Distribution
Brand NameK 180 OPHTHALMOSCOPE
Version Model Number2,5 V
Catalog NumberC-001.30.206
Company DUNS315274563
Company NameHeine Optotechnik GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com
Phone+1 (603) 742-7103
Emailservice@heine-na.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104053755120017 [Primary]

FDA Product Code

HLJOphthalmoscope, Battery-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-06-28
Device Publish Date2022-12-15

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04053755137039 - GAMMA C.32024-11-25
04053755179206 - BETA 400 LED F.O. OTOSCOPE2024-08-14
04053755201853 - visionPRO Mac 22024-08-14
04053755202423 - MINI3000 LED OTOSCOPE 2024-08-14 available also in blue
04053755202508 - BETA 200 LED RETINOSCOPE2024-07-24

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