Duns Number:002397347
Device Description: Standard Spike Dispensing Pin
Catalog Number
412013
Brand Name
Dispensing Pin
Version/Model Number
412013
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"
Yes
For Single-Use
Yes
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
LHI
Product Code Name
Set, i.V. Fluid transfer
Public Device Record Key
f554f5f9-3e2f-41eb-a2ee-f0233ac8d6fc
Public Version Date
November 06, 2020
Public Version Number
6
DI Record Publish Date
September 23, 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 | 16 |
2 | A medical device with a moderate to high risk that requires special controls. | 277 |
U | Unclassified | 2 |