Duns Number:422528088
Device Description: Safety lancets are sterile, single use medical devices intended for capillary blood sampli Safety lancets are sterile, single use medical devices intended for capillary blood sampling. Intended users are healthcare professionals and lay users.
Catalog Number
7155
Brand Name
Acti-Lance, safety lancet
Version/Model Number
Lite, 28G
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)
-
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
0ecf1a9f-acbf-4f04-99f8-acad86760457
Public Version Date
May 25, 2020
Public Version Number
1
DI Record Publish Date
May 17, 2020
Package DI Number
15901549097013
Quantity per Package
20
Contains DI Package
05901549097016
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 |