Duns Number:793169512
Device Description: 125SH 35X43CM (14X17IN) DVC CE SBOX
Catalog Number
8795247
Brand Name
DRYVIEW DVC Laser Imaging Film
Version/Model Number
DRYVIEW DVC Laser Imaging Film
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 26, 2018
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
3f24f315-2c46-478a-885a-526e299e1592
Public Version Date
July 30, 2018
Public Version Number
3
DI Record Publish Date
September 16, 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 | 328 |
2 | A medical device with a moderate to high risk that requires special controls. | 688 |