HD CAMERA HEAD

GUDID 04953170336669

CH-S190-08-LB HD ULTRA-LIGHT URO CAMERA

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscope video camera
Primary Device ID04953170336669
NIH Device Record Key3377c17a-a1ae-43c9-8798-1e0bba1a5214
Commercial Distribution StatusIn Commercial Distribution
Brand NameHD CAMERA HEAD
Version Model NumberOLYMPUS CH-S190-08-LB
Company DUNS711789789
Company NameOLYMPUS MEDICAL SYSTEMS CORP.
Device Count1
DM Exempttrue
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)401-1086
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170336669 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NWBEndoscope, accessories, narrow band spectrum

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170336669]

Ethylene Oxide;High-level Disinfectant


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-10-08
Device Publish Date2016-09-21

On-Brand Devices [HD CAMERA HEAD]

04953170336669CH-S190-08-LB HD ULTRA-LIGHT URO CAMERA
04953170268267"OTV-S7PROH-HD-L08E HD URO CAMERA"

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