Duns Number:422528088
Device Description: droplet ® personal lancets are sterile, single use medical devices intended to be used wit droplet ® personal lancets are sterile, single use medical devices intended to be used with a lancing device by lay users for capillary blood sampling.
Catalog Number
7162
Brand Name
droplet ® personal lancets
Version/Model Number
30G
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
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
e55617f1-e5b7-4726-875c-00b0ba29667a
Public Version Date
December 09, 2019
Public Version Number
1
DI Record Publish Date
December 01, 2019
Package DI Number
15907996091796
Quantity per Package
96
Contains DI Package
05907996091799
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |