Duns Number:713565195
Device Description: MEDICAL DRY IMAGING FILM 100NIF 35x43
Catalog Number
4741014245
Brand Name
FUJI MEDICAL DRY FILM
Version/Model Number
DI-AL 35X43 100 +
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
LMC
Product Code Name
Camera, multi format, radiological
Public Device Record Key
b1156ebb-1c11-4618-8ae5-88140bc69b71
Public Version Date
December 04, 2020
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
14547410142454
Quantity per Package
5
Contains DI Package
04547410142457
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 43 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 324 |
| 3 | A medical device with high risk that requires premarket approval | 1 |