VIDEO DUODENOSCOPE

GUDID 04961333240142

C.A.P. HD DUODENOSCOPE (US USED)

PENTAX OF AMERICA, INC.

Flexible video duodenoscope, reusable
Primary Device ID04961333240142
NIH Device Record Keyccb75880-ad7f-4ac5-afbb-5631a14be9f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameVIDEO DUODENOSCOPE
Version Model NumberED34-I10T-US
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
GS104961333240142 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDTDuodenoscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04961333240142]

Ethylene Oxide;High-level Disinfectant


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-01-23
Device Publish Date2018-03-12

On-Brand Devices [VIDEO DUODENOSCOPE]

04961333240142C.A.P. HD DUODENOSCOPE (US USED)
04961333240135VIDEO DUODENOSCOPE (USED)
04961333240128VIDEO DUODENOSCOPE - I10 STANDARD (INTERNATIONAL USED)
04961333232956C.A.P. HD DUODENOSCOPE (US NEW)
04961333232420ED-3490TK VIDEO DUODENOSCOPE (REFURBISHED)

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