Duns Number:016069284
Device Description: Pressure Activated Safety Heel-Stick Lancet
Catalog Number
1006
Brand Name
MediHeel
Version/Model Number
1006
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
August 28, 2025
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
FMK
Product Code Name
Lancet, Blood
Public Device Record Key
b2dcad87-ac47-4af7-914e-ec9f9ed0834f
Public Version Date
September 07, 2020
Public Version Number
1
DI Record Publish Date
August 28, 2020
Package DI Number
00732671010063
Quantity per Package
50
Contains DI Package
10732671110067
Package Discontinue Date
August 28, 2025
Package Status
In Commercial Distribution
Package Type
Chipboard 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 |