Duns Number:137217043
Catalog Number
104-9010
Brand Name
SCOTT'S VPS HP REG-SET REGULAR BODY 4/bx
Version/Model Number
104-9010
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
ELW
Product Code Name
Material, Impression
Public Device Record Key
a4d8d951-9eab-47cb-9b49-dbf8b7ce8f12
Public Version Date
August 26, 2020
Public Version Number
3
DI Record Publish Date
February 13, 2017
Package DI Number
D778104901016
Quantity per Package
4
Contains DI Package
D778104901005
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
KIT
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1050 |
2 | A medical device with a moderate to high risk that requires special controls. | 90 |