SINUSCOPE

GUDID 04961333230570

Sinuscope 4.0mm, 70 Wide Angle

PENTAX OF AMERICA, INC.

Rigid nasopharyngoscope
Primary Device ID04961333230570
NIH Device Record Keycecc5beb-cb6c-487a-8e25-f6490dcd7c09
Commercial Distribution StatusIn Commercial Distribution
Brand NameSINUSCOPE
Version Model Number8856-WA
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 Diameter4 Millimeter
Angle70 degree
Outer Diameter4 Millimeter
Angle70 degree
Outer Diameter4 Millimeter
Angle70 degree
Outer Diameter4 Millimeter
Angle70 degree
Outer Diameter4 Millimeter
Angle70 degree
Outer Diameter4 Millimeter
Angle70 degree
Outer Diameter4 Millimeter
Angle70 degree
Outer Diameter4 Millimeter
Angle70 degree
Outer Diameter4 Millimeter
Angle70 degree
Outer Diameter4 Millimeter
Angle70 degree
Outer Diameter4 Millimeter
Angle70 degree
Outer Diameter4 Millimeter
Angle70 degree
Outer Diameter4 Millimeter
Angle70 degree
Outer Diameter4 Millimeter
Angle70 degree
Outer Diameter4 Millimeter
Angle70 degree
Outer Diameter4 Millimeter
Angle70 degree
Outer Diameter4 Millimeter
Angle70 degree
Outer Diameter4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104961333230570 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOBNasopharyngoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-04-06

On-Brand Devices [SINUSCOPE]

049613332316528853 SINUSCOPE
04961333230570Sinuscope 4.0mm, 70 Wide Angle
04961333230563Sinuscope 4.0mm, 45 Wide Angle
04961333230556Sinuscope 4.0mm, 30 Wide Angle
04961333230549Sinuscope 4.0mm, 0 Wide Angle
04961333230525Sinuscope 2.7mm, 30 Wide Angle
04961333230518Sinuscope 2.7mm, 0 Wide Angle
04961333230211Sinuscope 4.0mm, 70
04961333230204Sinuscope 4.0mm, 45
04961333230198Sinuscope 4.0mm, 30
04961333230181Sinuscope 4.0mm, 0
04961333230174Sinuscope 2.7mm, 70
04961333230167Sinuscope 2.7mm, 30
04961333230150Sinuscope 2.7mm, 0

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