FIBER LARYNGOSCOPE

GUDID 04961333232796

FIBER NASO PHARYNGO LARYNGOSCOPE (REFURBISHED)

PENTAX OF AMERICA, INC.

Flexible fibreoptic nasopharyngolaryngoscope
Primary Device ID04961333232796
NIH Device Record Key55f53ef5-f3d4-4d4d-b031-0cff0d6ea583
Commercial Distribution StatusIn Commercial Distribution
Brand NameFIBER LARYNGOSCOPE
Version Model NumberFNL-7RP3
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 Identifiers

Device Issuing AgencyDevice ID
GS104961333232796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOBNasopharyngoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04961333232796]

Ethylene Oxide;High-level Disinfectant


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 [FIBER LARYNGOSCOPE]

04961333232796FIBER NASO PHARYNGO LARYNGOSCOPE (REFURBISHED)
04961333232789FIBER NASO PHARYNGO LARYNGOSCOPE (REFURBISHED)
04961333232772FIBER NASO PHARYNGO LARYNGOSCOPE (REFURBISHED)
04961333232765NASO-PHARYNGO-LRNGO PORTABLE (REFURBISHED)
04961333232758FIBER NASO PHARYNGO LARYNGOSCOPE INTUB 3 (REFURBISHED)

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