Duns Number:023904428
Device Description: LANCET, PUSH-BTN SFTY 17G NDL 2.0MM LF YLW (100/BX)
Catalog Number
-
Brand Name
McKesson
Version/Model Number
16-PBSL17GX
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
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Public Device Record Key
71418afa-f5a3-473f-9184-37becdf09f09
Public Version Date
October 28, 2022
Public Version Number
1
DI Record Publish Date
October 20, 2022
Package DI Number
40612479265224
Quantity per Package
20
Contains DI Package
20612479265213
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 |