Duns Number:007941230
Device Description: Lancet Blood Sampling Safety High Flow 21 Gauge X 2.0 Millimeter Depth Unistik 3 Dark Gray Lancet Blood Sampling Safety High Flow 21 Gauge X 2.0 Millimeter Depth Unistik 3 Dark Gray Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
MC5060
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
52f37941-7426-4276-b5a6-1ebedb547798
Public Version Date
October 27, 2020
Public Version Number
1
DI Record Publish Date
October 19, 2020
Package DI Number
50885632117945
Quantity per Package
20
Contains DI Package
30885632117941
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 |