Duns Number:023904428
Device Description: Heel Incision Device NEWBORN STERILE -SAFETY LANCETS 1 mm Incision Depth x 2.5 mm Incision Heel Incision Device NEWBORN STERILE -SAFETY LANCETS 1 mm Incision Depth x 2.5 mm Incision Length
Catalog Number
-
Brand Name
McKesson
Version/Model Number
16-PAHL2.5G1.0
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
1d14d496-9aa8-49a1-8d10-7f1554dbc9e7
Public Version Date
July 28, 2020
Public Version Number
1
DI Record Publish Date
July 20, 2020
Package DI Number
20612479223404
Quantity per Package
50
Contains DI Package
10612479223391
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |