Duns Number:692076161
Device Description: MEDICAL IMAGING FILM
Catalog Number
-
Brand Name
DRYPRO SD-Q2
Version/Model Number
AE62
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)
Yes
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
9e20aae5-d79a-4bc9-934f-d580eb91a055
Public Version Date
September 28, 2022
Public Version Number
1
DI Record Publish Date
September 20, 2022
Package DI Number
14560141950587
Quantity per Package
4
Contains DI Package
04560141950580
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 130 |