NDS

GUDID 04961333244102

ZWIRE G2 ACC. RADI. ULTRA 27 (PAIR)

PENTAX OF AMERICA, INC.

Medical monitor/light stand Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Mobile medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered Transportable medical equipment stand, non-powered
Primary Device ID04961333244102
NIH Device Record Key81f411f1-38de-4aec-b275-735ec1e568c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameNDS
Version Model NumberNDS90Z0156
Company DUNS083211284
Company NamePENTAX OF AMERICA, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 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
GS104961333244102 [Primary]

FDA Product Code

KQMCamera, Surgical And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-23
Device Publish Date2018-03-15

On-Brand Devices [NDS]

04961333244539NDS 32" LED DISPLAY, W/O FIBER
04961333244522RADIANCE 55" G2 LED, W/SINGLE FIBER
04961333244126NDS CONDUCTOR G2 BASE UNIT(HD STRM INCL)
04961333244119ZWIRE G2 ACC. RADI. ULTRA 27 (SNGL)
04961333244102ZWIRE G2 ACC. RADI. ULTRA 27 (PAIR)
0496133324409627" RADIANCE ULTRA MONITOR
04961333244089ZEROWIRE G2 PAIR (RX & TX)
04961333244072NDS RADIANCE ULTRA 32" ANALOG MONITOR
0496133324406542" RADIANCE G2 LED WITH SINGLE FIBER
04961333244058RADIANCE 24" G2 W/SINGLE FIBER
04961333244041NDS 21" ENDOVUE DISPLAY
04961333244034NDS 21" ENDOVUE DISPLAY
04961333244027NATIONAL DISPLAY 26" RADIANCE HD LED MON
04961333244010NDS 24" LED MONITOR
04961333244003NDS 24" ENDOVUE MONITOR
04961333243280NDS CONDUCTOR VIDEO SWITCHING PACKAGE
04961333240906NDS 19IN RADIANCE HD MONITOR MED GRADE
04961333240739POWER SUPPLY-NDS 23" AND 32" MONITOR
04961333240722POWER SUPPLY- NDS 26" LED MONITOR
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