VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE

GUDID 04961333240456

ULTRASLIM NASOLARYNGOSCOPE (USED)

PENTAX OF AMERICA, INC.

Flexible video laryngoscope
Primary Device ID04961333240456
NIH Device Record Key6ad63bc3-7563-4a81-b269-bed5f61f3998
Commercial Distribution StatusIn Commercial Distribution
Brand NameVIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE
Version Model NumberVNL8-J10
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 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
GS104961333240456 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOBNasopharyngoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04961333240456]

Liquid Chemical;High-level Disinfectant


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-03-13

On-Brand Devices [VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE]

04961333240463VIDEO NASOLARYNGOSCOPE (FOR VIVIDEO) (USED)
04961333240456ULTRASLIM NASOLARYNGOSCOPE (USED)
04961333240449THERAPEUTIC NASOLARYNGOSCOPE (USED)
04961333240432VIDEO NASO PHARYNGO LARYNGOSCOPE (USED)
04961333240425SLIM NASOLARYNGOSCOPE (USED)
04961333240418VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE (USED)
04961333240401VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE (USED)
04961333239795VIDEO NASOLARYNGOSCOPE (FOR VIVIDEO)
04961333233960VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE (REFURBISHED)

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