Duns Number:244897773
Device Description: MPD Lancets Ultra Thin. 3 Bevel point, sterile tip. Single Use.Box of 100 Color PurpleSt MPD Lancets Ultra Thin. 3 Bevel point, sterile tip. Single Use.Box of 100 Color PurpleSterilized by Radiation
Catalog Number
P0361
Brand Name
MPD Lancet Ultra Thin (Box of 100)
Version/Model Number
1
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
395252cf-c58d-4763-a59f-1ff21780fe24
Public Version Date
September 29, 2020
Public Version Number
3
DI Record Publish Date
February 21, 2020
Package DI Number
00628465005615
Quantity per Package
140
Contains DI Package
00628465003611
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |