FDA UDI In Commercial Distribution 🇺🇸 United States

Varex Imaging

DI: 08718755001655 · Model: 19407-09 · Varex Imaging Nederland B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Varex Imaging
Primary DI
08718755001655
Version / Model
19407-09
Company Name
Varex Imaging Nederland B.V.
Labeler DUNS
413223942
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-07-24
Public Version
2
Public Version Date
2021-03-18
Public Version Status
Update
Public Device Record Key
5eb60dc0-5455-4f4a-9da1-9497e51a74a8

Device Description

The device is intended to be used in medical diagnostic applications with restrictions to human diagnostics as an accessory of an X-ray system in a professional healthcare facility environment and is intended to be holding image receptor. The device is one out of the Harmony 3-series.

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IXY Holder, Radiographic Cassette, Wall-Mounted

GMDN Terms

Code Name
14473 X-ray film cassette holder

Identifiers

Type ID
Primary 08718755001655