Duns Number:244897773
Device Description: 23G x 1.8mm MPD Safety LancetBox of 100Single useSterileSafeNeedle is fully shielded befor 23G x 1.8mm MPD Safety LancetBox of 100Single useSterileSafeNeedle is fully shielded before and after useSterilized by gamma irradiationComfortableHigh Quality Tri-bevel point with high speed penetrationTri-Bevel tip ensures good blood flowOptimal ergonomic designConvenientPre-loaded and pressure activated device Less pressure power.
Catalog Number
P1455
Brand Name
AboutTime MPD 23G x1.8mm Safety Lancet
Version/Model Number
1
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
59761d76-bcf7-43a0-b810-f5334f7350f0
Public Version Date
March 04, 2020
Public Version Number
1
DI Record Publish Date
February 25, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |