FDA UDI In Commercial Distribution 🇺🇸 United States

EB/RA Film

DI: 40889978174382 · Model: EB/RA Film · CARESTREAM HEALTH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100

Basic Information

Brand Name
EB/RA Film
Primary DI
40889978174382
Version / Model
EB/RA Film
Catalog Number
8174385
Company Name
CARESTREAM HEALTH, INC.
Labeler DUNS
793169512
Distribution Status
In Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2016-09-16
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
3868bbce-1408-438e-bf73-59edab9829b9

Device Description

100SH 35X43CM EB/RA 4153

Device Characteristics

Single Use
Yes
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
Yes
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
IWZ Film, radiographic

GMDN Terms

Code Name
40980 Medical x-ray film, non-screen

Identifiers

Type ID
Package 60889978174386
Primary 40889978174382
Unit of Use 00889978174384