Duns Number:832875905
Device Description: Prodigy Pressure Activated Safety Lancets 21G (100 ct)
Catalog Number
24-082341
Brand Name
Prodigy Pressure Activated Safety Lancets
Version/Model Number
24-082341
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"
-
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
b5ffbbb3-ea1c-44c7-8187-5f324cefd430
Public Version Date
September 21, 2018
Public Version Number
1
DI Record Publish Date
August 21, 2018
Package DI Number
30384840823410
Quantity per Package
10
Contains DI Package
00384840823419
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Corrugated Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 5 |
2 | A medical device with a moderate to high risk that requires special controls. | 8 |