Duns Number:422528088
Device Description: Sterile,single-use safety lancets for capillary blood sampling.
Catalog Number
7046
Brand Name
Medlance Plus, safety lancet
Version/Model Number
Special, blade 0.8 mm 2.0 mm
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
b0e35dbb-8672-4c28-8192-1e030dfb01d7
Public Version Date
February 28, 2020
Public Version Number
1
DI Record Publish Date
February 20, 2020
Package DI Number
15907506237133
Quantity per Package
10
Contains DI Package
05907506237136
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 |