HD AUTOCLAVABLE CAMERA HEAD

GUDID 04953170252914

"OTV-S7PROH-HD-10E CAM HEAD 1.0X EYEPIECE"

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscope video camera
Primary Device ID04953170252914
NIH Device Record Key3d4097fe-fac8-4aaf-9b34-61fbfa51660a
Commercial Distribution StatusIn Commercial Distribution
Brand NameHD AUTOCLAVABLE CAMERA HEAD
Version Model NumberOTV-S7ProH-HD-10E
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
GS104953170252914 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, general & plastic surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170252914]

High-level Disinfectant;Ethylene Oxide;Moist Heat or Steam Sterilization


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 AUTOCLAVABLE CAMERA HEAD]

04953170310782OLYMPUS CH-S190-XZ-Q
04953170252945OTV-S7ProH-HD-10Q
04953170252914"OTV-S7PROH-HD-10E CAM HEAD 1.0X EYEPIECE"
04953170228865OTV-S7ProH-HD-12Q
04953170228834"OTV-S7PROH-HD-12E CAM HEAD 1.2X EYEPIECE"

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