Duns Number:016069284
Device Description: 33ga Twist Lancets
Catalog Number
934
Brand Name
PIP
Version/Model Number
934
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 2025
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
aabd00c0-61b3-4ee7-8a4b-d0f8c108e168
Public Version Date
February 05, 2020
Public Version Number
2
DI Record Publish Date
December 30, 2019
Package DI Number
20732671209348
Quantity per Package
100
Contains DI Package
10732671109344
Package Discontinue Date
December 30, 2025
Package Status
In Commercial Distribution
Package Type
Corrugate Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 5 |