Duns Number:023904428
Device Description: Safety Lancets PUSH-BUTTON HAEMOLANCE PLUS STERILE 28G x 1.6 mm
Catalog Number
-
Brand Name
McKesson
Version/Model Number
16-PBHPSL28G1.6
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
cccf772a-f600-41ca-9b01-7594a5e85942
Public Version Date
July 09, 2021
Public Version Number
2
DI Record Publish Date
July 14, 2020
Package DI Number
00612479210400
Quantity per Package
20
Contains DI Package
00612479210394
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |