CANNULA

GUDID 14953170043885

OLYMPUS MEDICAL SYSTEMS CORP.

Cholangiopancreatography catheter, reusable
Primary Device ID14953170043885
NIH Device Record Key18fa75f2-ca4a-465f-abc1-352c042444fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameCANNULA
Version Model NumberPR-126Q-1
Company DUNS711789789
Company NameOLYMPUS MEDICAL SYSTEMS CORP.
Device Count2
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 Latextrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170043888 [Primary]
GS114953170043885 [Package]
Contains: 04953170043888
Package: [1 Units]
In Commercial Distribution
GS184953170043884 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODDEndoscopic retrograde cholangiopancreatography (ERCP) cannula

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[14953170043885]

Moist Heat or Steam Sterilization


[14953170043885]

Moist Heat or Steam Sterilization


[14953170043885]

Moist Heat or Steam Sterilization


[14953170043885]

Moist Heat or Steam Sterilization


[14953170043885]

Moist Heat or Steam Sterilization


[14953170043885]

Moist Heat or Steam Sterilization


[14953170043885]

Moist Heat or Steam Sterilization


[14953170043885]

Moist Heat or Steam Sterilization


[14953170043885]

Moist Heat or Steam Sterilization


[14953170043885]

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 [CANNULA]

14953170154680PR-326Q
14953170154659PR-313Q
14953170154635PR-310Q
14953170154604PR-309Q
14953170154574PR-304Q
14953170043885PR-126Q-1
14953170043847PR-113Q-1
14953170043762PR-110Q-1
14953170043724PR-109Q-1
14953170043601PR-104Q-1
14953170043571PR-24Q-1
14953170043168PR-2B-1

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