Duns Number:049735438
Device Description: Twist and Cap Lancents; 28 Gauge; Easy to Open Twist and Re-Cap Design; Ultra-Thin Tri-Bev Twist and Cap Lancents; 28 Gauge; Easy to Open Twist and Re-Cap Design; Ultra-Thin Tri-Bevel Tip; Enclosed in Sealed, Protective Bag; Universal Design Fits Most Lancing Devices
Catalog Number
ZPL20028A
Brand Name
CARDINAL HEALTH ESSENTIALS
Version/Model Number
ZPL20028A
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
Lancet, blood
Public Device Record Key
e626cff4-e5c3-463c-85ef-679f6fd28005
Public Version Date
April 22, 2019
Public Version Number
1
DI Record Publish Date
April 12, 2019
Package DI Number
50888499009965
Quantity per Package
50
Contains DI Package
00888499009960
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 | 45 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |