Duns Number:388000270
Device Description: S-Monovette® 1.2ml K3E
Catalog Number
06.1661.100
Brand Name
S-Monovette®
Version/Model Number
06.1661.100
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JKA
Product Code Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Public Device Record Key
00b95b7e-ce25-4ab1-a0ea-c9bb9090e83a
Public Version Date
April 01, 2020
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
04038917373388
Quantity per Package
500
Contains DI Package
04038917373395
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |