Duns Number:010016319
Device Description: FILM FSS-58 D ADULT SINGLE BUTTERFLY PACKETS F SPEED, FILM INTRAORAL X-RAY
Catalog Number
-
Brand Name
FILM FSS-58 D ADULT SINGLE BUTTERFLY PACKETS F SPEED
Version/Model Number
19620
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
9f7fba96-69e4-49d2-8bff-7967f1258c81
Public Version Date
March 09, 2020
Public Version Number
1
DI Record Publish Date
February 28, 2020
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 |