N/A

GUDID 04961333242825

BRUSH CLEANING REUSABLE (2/PK)

PENTAX OF AMERICA, INC.

Endoscope cleaning brush, reusable
Primary Device ID04961333242825
NIH Device Record Keye0ea9705-e468-44fa-b8de-5ea965c4ada9
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberCS-6002SNK
Company DUNS083211284
Company NamePENTAX OF AMERICA, INC.
Device Count2
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 Dimensions

Outer Diameter6 Millimeter
Length20 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104961333242825 [Primary]
GS114961333242822 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOQBronchoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04961333242825]

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

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04961333245222LAMP FOR EPK-3000
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04961333244416FILM PACK B&W 240 PRINTS 897MD 10PC
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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
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04961333244256CABLE, RGB W/SYNC 6FT. FOR EPK
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04961333244201CBL,BNC-BNC,12 VIDEO
04961333244195HEAVY DUTY MONITOR POLE STAND
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04961333244171STANDARD BITE BLOCKS, 3 PIECES
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04961333243419SUCTION VALVE, 2 PCS
04961333243402VALVE, SUCTION 10 PCS
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