ZUTRON

GUDID 04961333244478

PENTAX LEAK TESTER HANDHLD

PENTAX OF AMERICA, INC.

Endoscope leak tester, mechanical
Primary Device ID04961333244478
NIH Device Record Key39c2c4ad-02e7-4623-ab9d-e3169cb22a8e
Commercial Distribution StatusIn Commercial Distribution
Brand NameZUTRON
Version Model NumberZUTR10002P
Company DUNS083211284
Company NamePENTAX OF AMERICA, INC.
Device Count1
DM Exemptfalse
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104961333244478 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FCYBulb, Inflation, For Endoscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-15

On-Brand Devices [ZUTRON]

04961333244515ZUTRON AUTO LEAK TESTER POWER SUPPLY
04961333244508LEAK TESTER - WALL MOUNT
04961333244492ZUTRON AUTOMATIC LEAK TESTER C
04961333244485LEAK TESTER - COUNTER
04961333244478PENTAX LEAK TESTER HANDHLD
04961333244461LEAK TESTER ADAPTER

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.