RIGID SCOPES

GUDID 04961333240531

RIGID ENDOSCOPE 70 DEG. 10MM

PENTAX OF AMERICA, INC.

Rigid nasopharyngoscope
Primary Device ID04961333240531
NIH Device Record Keyfeba1063-1839-46ca-a437-188fde7badd3
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIGID SCOPES
Version Model Number9106
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 Dimensions

Angle70 degree
Outer Diameter9.5 Millimeter
Angle70 degree
Outer Diameter9.5 Millimeter
Angle70 degree
Outer Diameter9.5 Millimeter
Angle70 degree
Outer Diameter9.5 Millimeter
Angle70 degree
Outer Diameter9.5 Millimeter
Angle70 degree
Outer Diameter9.5 Millimeter
Angle70 degree
Outer Diameter9.5 Millimeter
Angle70 degree
Outer Diameter9.5 Millimeter
Angle70 degree
Outer Diameter9.5 Millimeter
Angle70 degree
Outer Diameter9.5 Millimeter
Angle70 degree
Outer Diameter9.5 Millimeter
Angle70 degree
Outer Diameter9.5 Millimeter
Angle70 degree
Outer Diameter9.5 Millimeter
Angle70 degree
Outer Diameter9.5 Millimeter
Angle70 degree
Outer Diameter9.5 Millimeter
Angle70 degree
Outer Diameter9.5 Millimeter
Angle70 degree
Outer Diameter9.5 Millimeter
Angle70 degree
Outer Diameter9.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104961333240531 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EQLLaryngostroboscope

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04961333240531]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant


[04961333240531]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant


[04961333240531]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant


[04961333240531]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant


[04961333240531]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant


[04961333240531]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant


[04961333240531]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant


[04961333240531]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant


[04961333240531]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant


[04961333240531]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant


[04961333240531]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant


[04961333240531]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant


[04961333240531]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant


[04961333240531]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant


[04961333240531]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant


[04961333240531]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant


[04961333240531]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant


[04961333240531]

Liquid Chemical;Ethylene Oxide;High-level Disinfectant


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-02-26

On-Brand Devices [RIGID SCOPES]

04961333240555RIDID ENDOSCOPE,STERRAD NX CO
04961333240548RIGID ENDOSCOPE 70 DEG. 6MM
04961333240531RIGID ENDOSCOPE 70 DEG. 10MM

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