FDA UDI In Commercial Distribution 🇺🇸 United States

Duet DRF

DI: 07290012104701 · Model: 63111976 · C.M.T. MEDICAL TECHNOLOGIES LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Duet DRF
Primary DI
07290012104701
Version / Model
63111976
Catalog Number
63640509
Company Name
C.M.T. MEDICAL TECHNOLOGIES LTD.
Labeler DUNS
600084453
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-09-10
Public Version
3
Public Version Date
2021-06-10
Public Version Status
Update
Public Device Record Key
6f4e8a3e-91fd-4b5e-9642-41e162c6ff6d

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JAA System, X-Ray, Fluoroscopic, Image-Intensified

GMDN Terms

Code Name
37679 Stationary general-purpose fluoroscopic x-ray system, digital

Identifiers

Type ID
Primary 07290012104701

Premarket Submissions

Submission Number Supplement Number
K103038 000