Duns Number:016069284
Device Description: MediCore's "LiteTouch Brand Insulin Pen Needle
Catalog Number
-
Brand Name
LiteTouch
Version/Model Number
531
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
ec72fa0c-a656-4227-8366-8689ce2dce0b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 01, 2016
Package DI Number
30732671305313
Quantity per Package
4
Contains DI Package
20732671205319
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Corrogate carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |