RIGID SHEATH FOR LTF-190-10-3D

GUDID 04953170340741

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscope sheath, reusable
Primary Device ID04953170340741
NIH Device Record Key0ac541db-e251-4794-9b67-c52108982c8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIGID SHEATH FOR LTF-190-10-3D
Version Model NumberMAJ-2079
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 Batchtrue
Serial Numberfalse
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
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170340741 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, general & plastic surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170340741]

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


[04953170340741]

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


[04953170340741]

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


[04953170340741]

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


[04953170340741]

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


[04953170340741]

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


[04953170340741]

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


[04953170340741]

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


[04953170340741]

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


[04953170340741]

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


[04953170340741]

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


[04953170340741]

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


[04953170340741]

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


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-03-11
Device Publish Date2016-09-21

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