N/A

GUDID 04961333243389

SEAL,CHAN INLET,RBBR 10PCS (STD)

PENTAX OF AMERICA, INC.

Endoscope working-channel seal
Primary Device ID04961333243389
NIH Device Record Keyab37045a-4411-421d-a59b-1dc0256eba8e
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberKUMOF-B173K
Company DUNS083211284
Company NamePENTAX OF AMERICA, INC.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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
GS104961333243389 [Primary]
GS114961333243386 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDSGastroscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04961333243389]

Ethylene Oxide;Moist Heat or Steam Sterilization;High-level Disinfectant;Sound Waves

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-14

On-Brand Devices [N/A]

04961333245406v4.0 CSL WIN10 UPGRADE
04961333245314MS SQL ENT - 8 CORE LIC (RUNTIME)
04961333245307MS SQL ENT - 4 CORE LIC (RUNTIME)
04961333245291STANDALONE IMAGE CAPTURE PC
04961333245284KEYBOARD FOR EPK-3000
04961333245277CBL,DVID-DVID,6
04961333245260CBL,3.5ST-3.5ST,5,EPK-3000
04961333245253CBL,RGB,9DM-4BNC,5,EPK-3000
04961333245246CBL,BNC-BNC,6, EPK-3000
04961333245239FOOTSWITCH, EPK-3000
04961333245222LAMP FOR EPK-3000
04961333245215FORCEPS TOOTHEDCUP,1.8DIA 60L
04961333245192MIC PRE-AMP KIT (ROLLS MP-13)
04961333245185DEMO CASE FOR POLE STAND
04961333245178DEMO CASE FOR SCOPE, PROCESSOR & MONITOR
04961333244706MS SQL STD SINGLE USER LICENSE
04961333244447SCOPE PROCESSOR/MONITOR INTEGRATION PKG
04961333244430CABLE MANAGEMENT CLIP (5 PACK)
04961333244423UP-X898MD B&W VIDEO PRINTER
04961333244416FILM PACK B&W 240 PRINTS 897MD 10PC
04961333244409FILM PACK 100 PRINTS RIBBON 55MD 2PC
04961333244393FILM PACK 200 PRINTS RIBBON 51MDU/D50
04961333244386FILM PACK 50 PRINTS RIBBON 21/20MD 4PC
04961333244348POWER STRIP/CABLE CLEAT
04961333244324POWER SUPPLY HOLDER/CABLE CLEAT
04961333244317TRAY 30.4 CM X 40.6 CM FOR 2"/5 CM POST
04961333244300HANDLE FOR 2"/5 CM POST
04961333244294UTILITY BASKET
04961333244287ADAPTER FOR 70K WITH FWJ
04961333244270ADAPTER FOR 70K W/O FWJ
04961333244263ADAPTER FOR EB-70K
04961333244256CABLE, RGB W/SYNC 6FT. FOR EPK
04961333244249CBL,4BNC-4BNC,25 VIDEO
04961333244232CBL,4BNC-4BNC,15 VIDEO
04961333244225CBL,BNC-BNC,6 VIDEO
04961333244218CBL,BNC-BNC,25 VIDEO
04961333244201CBL,BNC-BNC,12 VIDEO
04961333244195HEAVY DUTY MONITOR POLE STAND
04961333244188WATER BOTTLE, REUSABLE
04961333244171STANDARD BITE BLOCKS, 3 PIECES
04961333244164RUBBER SUCT VALVE 10 PCS DISPO
04961333243990MS SQL STD SINGLE SVR & USER LICENSE
04961333243983MS SQL STD - 8 CORE LICENSE
04961333243976MS SQL STD - 4 CORE LICENSE
0496133324396924" STANDARD MONITOR
04961333243952DUAL SCOPE HOLDER TYPE II FOR PREC. CART
04961333243945DRAWER, DEEP FOR PREC. CART
04961333243426BITE BLOCK 3PCS ST
04961333243419SUCTION VALVE, 2 PCS
04961333243402VALVE, SUCTION 10 PCS
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