Duns Number:010016319
Device Description: FILM INTRAORAL X-RAY, FILM DX-42 NO. 3 BITE-CHEX PAPER BITEWING D SPEED, 100pcs/box
Catalog Number
-
Brand Name
FILM DX-42 NO. 3 BITE-CHEX PAPER BITEWING D SPEED
Version/Model Number
18060-E
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
7e37daab-9876-4d43-9147-ac1fc7f91e0f
Public Version Date
July 09, 2020
Public Version Number
1
DI Record Publish Date
July 01, 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 |