Duns Number:008124539
Device Description: SensiLance, Button Activated Safety Lancets, Sterile, 26 Gauge Needle, 1.8mm Depth Setting
Catalog Number
-
Brand Name
SensiLance
Version/Model Number
7124
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMK
Product Code Name
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Public Device Record Key
db0e7e32-cef7-4a51-8524-43582be4346c
Public Version Date
May 12, 2022
Public Version Number
1
DI Record Publish Date
May 04, 2022
Package DI Number
00616784712437
Quantity per Package
10
Contains DI Package
00616784712420
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |