Duns Number:007941230
Device Description: Lancet Top Activated Safety Blood Sampling Low Flow Sterile Single Use Only Not Made With Lancet Top Activated Safety Blood Sampling Low Flow Sterile Single Use Only Not Made With Natural Rubber Latex Sterile 28 Gauge 1.2mm Depth Blue MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
TL2812
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
976671d4-4f71-46ce-bb08-957d194ec45b
Public Version Date
October 08, 2020
Public Version Number
1
DI Record Publish Date
September 30, 2020
Package DI Number
30885632070741
Quantity per Package
20
Contains DI Package
20885632070744
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |