Duns Number:002397347
Device Description: Chemo Dispensing Pin™ with Distal MINI-SPIKE® Plus
Catalog Number
412011
Brand Name
Mini-Spike®
Version/Model Number
412011
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 14, 2022
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)
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
13ba752f-03d6-4d85-af69-0213d3a3cdeb
Public Version Date
July 18, 2022
Public Version Number
6
DI Record Publish Date
September 23, 2016
Package DI Number
04046964040900
Quantity per Package
2
Contains DI Package
04046964040894
Package Discontinue Date
July 14, 2022
Package Status
Not in Commercial Distribution
Package Type
Carton
| 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 |