Duns Number:653632729
Device Description: Lancets are used to make punctures to obtain small blood specimens, aregenerally disposabl Lancets are used to make punctures to obtain small blood specimens, aregenerally disposable, and are commonly used by diabetes patient. The smallblood samples obtained can be tested for blood glucose, hemoglobin, andmany other blood components. Lancets are also used to prick the skin in skintesting for allergies.
Catalog Number
-
Brand Name
SAFETICET
Version/Model Number
SC-220
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
April 16, 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
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Public Device Record Key
8e41a4a0-26ec-4a77-b04e-1dfb07ac24b9
Public Version Date
April 28, 2022
Public Version Number
1
DI Record Publish Date
April 20, 2022
Package DI Number
08887629000244
Quantity per Package
100
Contains DI Package
08887629000213
Package Discontinue Date
April 16, 2025
Package Status
In Commercial Distribution
Package Type
box packaging
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |