Duns Number:010016319
Device Description: Adult size D x-ray film in vinyl packets. 150 per box, FILM DV-58 SILVER D ADULT VALUE PAK Adult size D x-ray film in vinyl packets. 150 per box, FILM DV-58 SILVER D ADULT VALUE PAK
Catalog Number
18200
Brand Name
Silver D Film
Version/Model Number
18200
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IWZ
Product Code Name
Film, Radiographic
Public Device Record Key
c8f49cdc-cf2a-4705-b3e3-ebeda1176191
Public Version Date
January 06, 2020
Public Version Number
3
DI Record Publish Date
August 15, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3215 |