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
7207
Brand Name
droplet ® personal lancet
Version/Model Number
33G
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
8e3ddaa9-1fe7-4b52-8ddf-9146d782da5c
Public Version Date
December 09, 2019
Public Version Number
1
DI Record Publish Date
December 01, 2019
Package DI Number
15901549097549
Quantity per Package
96
Contains DI Package
05901549097542
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 |