Duns Number:785966607
Device Description: Disposable Pipet, 500/bag
Catalog Number
NC-5071-002-500
Brand Name
ASI Disposible Stirrer Pipet
Version/Model Number
NC-5071-002-500
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K853857
Product Code
GTO
Product Code Name
Anti-Streptokinase
Public Device Record Key
619965d2-08a0-4edb-9d86-c011e75e0593
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 08, 2016
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 | 25 |
2 | A medical device with a moderate to high risk that requires special controls. | 115 |