Duns Number:244897773
Device Description: MPD Lancets Thin. 3 Bevel point, sterile tip. Single Use.23 GuageBox of 100 Color BlueSt MPD Lancets Thin. 3 Bevel point, sterile tip. Single Use.23 GuageBox of 100 Color BlueSterilized by Radiation
Catalog Number
P0351
Brand Name
MPD Lancet
Version/Model Number
Thin 23Ga
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
2bfc1568-5b0d-43dc-b824-b68aff024e31
Public Version Date
October 08, 2020
Public Version Number
1
DI Record Publish Date
September 30, 2020
Package DI Number
00628465105513
Quantity per Package
140
Contains DI Package
00628465003512
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 |