FDA.reportPublic FDA data

CIT Ortho

Primary DI
00850009724021
Brand
CIT Ortho
Company
CIT Ortho, LLC
Model
613034705
Device description
C Scope Handpiece
Published
2021-04-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203526000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203526000C Scope Visualization SystemCit Ortho2021-01-12HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850009724021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850009724021008500097240218500097240210850009724021

GMDN Terms#

Term, Definition table
TermDefinition
Rigid arthroscope, single-useA sterile endoscope with a rigid inserted portion intended for the visual examination and treatment of the interior of a joint [e.g., knee, shoulder, elbow, temporomandibular joint (TMJ)]. It is inserted into the body through an artificial orifice created by an incision made during arthroscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is commonly used to examine structural damage to a joint, often from sports injuries. The arthroscope eyepiece is normally interfaced with a video camera. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4407721421Ctownsley@clearimg.com

Regulatory Flags#

DUNS number
118006054
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850009724038CIT Ortho6130347062021-04-23
00850009724090CIT Ortho6130347082021-04-23
00850009724106CIT Ortho6130349002021-04-23
00850009724113CIT Ortho6130349012021-04-23
20850009724001CIT Ortho6130347002021-04-23
20850009724056CIT Ortho6130347012021-04-23
20850009724063CIT Ortho6130347022021-04-23

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