Duns Number:121621853
Device Description: Infant Collimation Shield-Non-Sterile 4 pack-Yellow
Catalog Number
-
Brand Name
RADPAD
Version/Model Number
5700-Y-NS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
KPY
Product Code Name
Shield, protective, personnel
Public Device Record Key
d7e9d74a-d41d-4532-ad8f-da360a8a75d4
Public Version Date
July 22, 2020
Public Version Number
3
DI Record Publish Date
January 19, 2017
Package DI Number
10852814003343
Quantity per Package
15
Contains DI Package
00852814003346
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 48 |