Duns Number:137217043
Catalog Number
188-2001
Brand Name
SCOTT'S SELECT ASPIRATING SYRINGE TYPE A
Version/Model Number
188-2001
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EJI
Product Code Name
Syringe, Cartridge
Public Device Record Key
e10e45a0-4a60-4416-b5cc-9da4eff40e93
Public Version Date
October 01, 2020
Public Version Number
3
DI Record Publish Date
November 26, 2018
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 | 1050 |
2 | A medical device with a moderate to high risk that requires special controls. | 90 |