CIT Ortho

GUDID 00850009724021

C Scope Handpiece

CIT Ortho, LLC

Rigid arthroscope, single-use Rigid arthroscope, single-use Rigid arthroscope, single-use Rigid arthroscope, single-use Rigid arthroscope, single-use Rigid arthroscope, single-use Rigid arthroscope, single-use Rigid arthroscope, single-use Rigid arthroscope, single-use Rigid arthroscope, single-use Rigid arthroscope, single-use Rigid arthroscope, single-use Rigid arthroscope, single-use Rigid arthroscope, single-use Rigid arthroscope, single-use
Primary Device ID00850009724021
NIH Device Record Key95cb63b3-bcea-4339-900f-991e3a449daf
Commercial Distribution StatusIn Commercial Distribution
Brand NameCIT Ortho
Version Model Number613034705
Company DUNS118006054
Company NameCIT Ortho, LLC
Device Count1
DM Exempttrue
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 Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone4407721421
EmailCtownsley@clearimg.com
Phone4407721421
EmailCtownsley@clearimg.com
Phone4407721421
EmailCtownsley@clearimg.com
Phone4407721421
EmailCtownsley@clearimg.com
Phone4407721421
EmailCtownsley@clearimg.com
Phone4407721421
EmailCtownsley@clearimg.com
Phone4407721421
EmailCtownsley@clearimg.com
Phone4407721421
EmailCtownsley@clearimg.com
Phone4407721421
EmailCtownsley@clearimg.com
Phone4407721421
EmailCtownsley@clearimg.com
Phone4407721421
EmailCtownsley@clearimg.com
Phone4407721421
EmailCtownsley@clearimg.com
Phone4407721421
EmailCtownsley@clearimg.com
Phone4407721421
EmailCtownsley@clearimg.com
Phone4407721421
EmailCtownsley@clearimg.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850009724021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXArthroscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-03
Device Publish Date2021-04-23

On-Brand Devices [CIT Ortho]

20850009724063C Scope Disposable Kit
20850009724056C Scope Disposable Kit
20850009724001C Scope Disposable Kit
00850009724113C Scope Demo Tablet
00850009724106C Scope Demo Handpiece
00850009724090C Scope Complete Package
00850009724038C Scope Tablet
00850009724021C Scope Handpiece

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.