Duns Number:121621853
Device Description: Verterbro/Kyphoplasty Drape - Red
Catalog Number
-
Brand Name
RADPAD
Version/Model Number
7400-R
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
IWQ
Product Code Name
Curtain, protective, radiographic
Public Device Record Key
54e3dc46-f6e0-4ff5-8d10-898b521b3988
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 25, 2016
Package DI Number
10852814003527
Quantity per Package
12
Contains DI Package
00852814003520
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 |