Sheath section

GUDID 04953170033971

OLYMPUS MEDICAL SYSTEMS CORP.

General-purpose endoscopic needle, reusable
Primary Device ID04953170033971
NIH Device Record Keyb6ee1394-e35a-44e0-978e-e25f32a5a720
Commercial Distribution StatusIn Commercial Distribution
Brand NameSheath section
Version Model NumberMAJ-69
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170033971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170033971]

Moist Heat or Steam Sterilization


[04953170033971]

Moist Heat or Steam Sterilization


[04953170033971]

Moist Heat or Steam Sterilization


[04953170033971]

Moist Heat or Steam Sterilization


[04953170033971]

Moist Heat or Steam Sterilization


[04953170033971]

Moist Heat or Steam Sterilization


[04953170033971]

Moist Heat or Steam Sterilization


[04953170033971]

Moist Heat or Steam Sterilization


[04953170033971]

Moist Heat or Steam Sterilization


[04953170033971]

Moist Heat or Steam Sterilization


[04953170033971]

Moist Heat or Steam Sterilization


[04953170033971]

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 [Sheath section]

04953170033971MAJ-69
04953170033810MAJ-074 SHEATH FOR INJECTION NEED NM-8/9

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