Duns Number:422528088
Device Description: The Droplet Genteel Lancing Device is used with disposable lancets to draw capillary blood The Droplet Genteel Lancing Device is used with disposable lancets to draw capillary blood from the fingertip or alternate sites for glucose testing or other testing utilizing small amount of blood.
Catalog Number
9150
Brand Name
droplet Genteel lancing device
Version/Model Number
n/a
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
K153670,K153670
Product Code
FMK
Product Code Name
Lancet, Blood
Public Device Record Key
cdfd18a6-50f0-4029-b8fc-766d0e0d317b
Public Version Date
October 01, 2021
Public Version Number
2
DI Record Publish Date
April 20, 2021
Package DI Number
15907996098771
Quantity per Package
24
Contains DI Package
05907996098774
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shipper box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |