Tube Sheath

GUDID 04953170044885

OLYMPUS MEDICAL SYSTEMS CORP.

Polypectomy endoscopic ligator, reusable Polypectomy endoscopic ligator, reusable Polypectomy endoscopic ligator, reusable Polypectomy endoscopic ligator, reusable Polypectomy endoscopic ligator, reusable Polypectomy endoscopic ligator, reusable Polypectomy endoscopic ligator, reusable Polypectomy endoscopic ligator, reusable Polypectomy endoscopic ligator, reusable Polypectomy endoscopic ligator, reusable Polypectomy endoscopic ligator, reusable Polypectomy endoscopic ligator, reusable
Primary Device ID04953170044885
NIH Device Record Keya0a24396-6eb2-40a0-af91-5c3ee8892991
Commercial Distribution StatusIn Commercial Distribution
Brand NameTube Sheath
Version Model NumberMAJ-252
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
GS104953170044885 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNDLigator, esophageal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04953170044885]

Moist Heat or Steam Sterilization


[04953170044885]

Moist Heat or Steam Sterilization


[04953170044885]

Moist Heat or Steam Sterilization


[04953170044885]

Moist Heat or Steam Sterilization


[04953170044885]

Moist Heat or Steam Sterilization


[04953170044885]

Moist Heat or Steam Sterilization


[04953170044885]

Moist Heat or Steam Sterilization


[04953170044885]

Moist Heat or Steam Sterilization


[04953170044885]

Moist Heat or Steam Sterilization


[04953170044885]

Moist Heat or Steam Sterilization


[04953170044885]

Moist Heat or Steam Sterilization


[04953170044885]

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 [Tube Sheath]

04953170044946MAJ-253 TEFLON SHEATH FOR HX-20U-1 LOOP
04953170044885MAJ-252
04953170044823MAJ-251
04953170032967MAJ-246
04953170032851MAJ-243

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