Duns Number:009831413
Device Description: Pro Advantage 25G low flow safety lancet purple 200/BX
Catalog Number
P929025
Brand Name
Pro Advantage
Version/Model Number
P929025
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
-
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
ee043dc1-59d8-470f-873e-43155277e27a
Public Version Date
October 24, 2018
Public Version Number
1
DI Record Publish Date
September 23, 2018
Package DI Number
M220P9290259
Quantity per Package
200
Contains DI Package
M220P9290253
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 | 224 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 192 |