FDA UDI In Commercial Distribution 🇺🇸 United States

CIT Ortho

DI: 20850009724001 · Model: 613034700 · CIT Ortho, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10

Basic Information

Brand Name
CIT Ortho
Primary DI
20850009724001
Version / Model
613034700
Company Name
CIT Ortho, LLC
Labeler DUNS
118006054
Distribution Status
In Commercial Distribution
Device Count in Pkg
10
Record Status
Published
Publish Date
2021-04-23
Public Version
2
Public Version Date
2023-11-17
Public Version Status
Update
Public Device Record Key
b104ebd9-9ef2-4a61-a80a-01afeff4106a

Device Description

C Scope Disposable Kit

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
HRX Arthroscope

GMDN Terms

Code Name
62570 Rigid optical arthroscope, single-use

Identifiers

Type ID
Primary 20850009724001
Unit of Use 00850009724007

Customer Contacts

Phone
4407721421

Premarket Submissions

Submission Number Supplement Number
K203526 000