FIBER INTUBATION SCOPE

GUDID 04961333240302

FIBEROPTICINTUBATIONSCOPE 2.6C 5.1TP ROP (USED)

PENTAX OF AMERICA, INC.

Flexible fibreoptic intubation laryngoscope
Primary Device ID04961333240302
NIH Device Record Key7bb4e99a-d4af-4b3a-a8ac-23ca71aaab0b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFIBER INTUBATION SCOPE
Version Model NumberFI-16RBS
Company DUNS083211284
Company NamePENTAX OF AMERICA, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS104961333240302 [Primary]

FDA Product Code

CALLaryngoscope, Non-Rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04961333240302]

Ethylene Oxide;High-level Disinfectant


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-04-12
Device Publish Date2018-03-12

On-Brand Devices [FIBER INTUBATION SCOPE]

04961333240326FIBEROPTICINTUBATIONSCOPE 1.2C 3.0TP ROP (USED)
04961333240319FIBEROPTICINTUBATIONSCOPE 2.4TP RO PLS (USED)
04961333240302FIBEROPTICINTUBATIONSCOPE 2.6C 5.1TP ROP (USED)
04961333240296FIBEROPTICINTUBATIONSCOPE 1.8C 4.1TP ROP (USED)
04961333240289FIBEROPTICINTUBATIONSCOPE 1.4C 3.4TP ROP (USED)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.