FDA UDI Not in Commercial Distribution 🇺🇸 United States

DUP Film WB

DI: 40889976046247 · Model: DUP Film WB · CARESTREAM HEALTH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100

Basic Information

Brand Name
DUP Film WB
Primary DI
40889976046247
Version / Model
DUP Film WB
Catalog Number
6046247
Company Name
CARESTREAM HEALTH, INC.
Labeler DUNS
793169512
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
100
Record Status
Published
Publish Date
2016-09-16
Public Version
3
Public Version Date
2019-04-22
Public Version Status
Update
Public Device Record Key
8f9721d3-e4f8-4467-a398-05fb13a77dfb
Distribution End Date
2019-04-12

Device Description

100SH 15X30-6X12 DUPLICATING WB

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 60889976046241
Primary 40889976046247
Unit of Use 00889976046249

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
4 – 10 Degrees Celsius