Duns Number:422528088
Device Description: Safety lancets are sterile, single use medical devices intended for capillary blood sampl Safety lancets are sterile, single use medical devices intended for capillary blood sampling.
Catalog Number
7367
Brand Name
Haemolance Plus, safety lancet
Version/Model Number
Low Flow, 25G 1.4mm
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)
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
efa53e2b-ad8a-4b3e-808f-a46f0a816a79
Public Version Date
June 14, 2021
Public Version Number
1
DI Record Publish Date
June 06, 2021
Package DI Number
15907506237942
Quantity per Package
45
Contains DI Package
05907506237945
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 |