Duns Number:793169512
Device Description: 125SH 35X43CM (14X17IN) DVB+ CE
Catalog Number
1069590
Brand Name
DRYVIEW DVB+ Laser Imaging Film
Version/Model Number
DRYVIEW DVB+ Laser Imaging Film
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
3147d3a1-83e0-4dea-b598-c4572e1a9279
Public Version Date
September 01, 2022
Public Version Number
3
DI Record Publish Date
December 22, 2017
Package DI Number
60889971069597
Quantity per Package
4
Contains DI Package
40889971069593
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 328 |
2 | A medical device with a moderate to high risk that requires special controls. | 688 |