Single Use Guiding Device

GUDID 14953170406178

OLYMPUS MEDICAL SYSTEMS CORP.

Bronchoscopic biopsy curette, flexible, single-use
Primary Device ID14953170406178
NIH Device Record Keyccb7ec2b-83a1-46e9-a564-7febddef2935
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle Use Guiding Device
Version Model NumberCC-220DR
Company DUNS711789789
Company NameOLYMPUS MEDICAL SYSTEMS CORP.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx
Phone+1(800)401-1086
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170406171 [Primary]
GS114953170406178 [Package]
Contains: 04953170406171
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTGBrush, biopsy, bronchoscope (non-rigid)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[14953170406178]

Ethylene Oxide


[14953170406178]

Ethylene Oxide


[14953170406178]

Ethylene Oxide


[14953170406178]

Ethylene Oxide


[14953170406178]

Ethylene Oxide


[14953170406178]

Ethylene Oxide


[14953170406178]

Ethylene Oxide


[14953170406178]

Ethylene Oxide


[14953170406178]

Ethylene Oxide


[14953170406178]

Ethylene Oxide


[14953170406178]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-15
Device Publish Date2021-09-07

Devices Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

04953170465949 - WATER CONTAINER2024-12-03
04953170465956 - WATER CONTAINER2024-12-03
04953170465963 - ENDOSCOPIC CO2 REGULATION UNIT2024-12-03
04953170465970 - EVIS EXERA III XENON LIGHT SOURCE2024-12-03
04953170454141 - VISERA S VIDEO SYSTEM CENTER2024-11-22
04953170452475 - EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE2024-10-14
04953170464935 - THUNDERBEAT 5 mm, 45 cm, Pistol Grip2024-09-17
04953170464973 - THUNDERBEAT 5 mm, 35 cm, Inline Grip2024-09-17

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