FDA UDI In Commercial Distribution 🇺🇸 United States

DIRECTVIEW CR Long-Length Cassette with PQ Screen

DI: 60889978010035 · Model: DIRECTVIEW CR Long-Length Cassette with PQ Screen · CARESTREAM HEALTH, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
DIRECTVIEW CR Long-Length Cassette with PQ Screen
Primary DI
60889978010035
Version / Model
DIRECTVIEW CR Long-Length Cassette with PQ Screen
Catalog Number
8010035
Company Name
CARESTREAM HEALTH, INC.
Labeler DUNS
793169512
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-16
Public Version
4
Public Version Date
2023-04-04
Public Version Status
Update
Public Device Record Key
165a160e-3421-4fe2-8cfd-eeb3f07d6826

Device Description

DV CR LONG-LENGTH CASS PKG W/ PQ

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
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EAM Screen, intensifying, radiographic
IXA Cassette, radiographic film

GMDN Terms

Code Name
44824 Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray

Identifiers

Type ID
Primary 60889978010035