Duns Number:008171162
Device Description: Assure Lance Safety Lancets 28g 30ct. Single-use disposable blood lancet should be used f Assure Lance Safety Lancets 28g 30ct. Single-use disposable blood lancet should be used for assisted blood drawn by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container.
Catalog Number
N/A
Brand Name
Assure® Lance Safety Lancets
Version/Model Number
980328
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
69b28683-d052-4601-9320-03bc83eab50a
Public Version Date
December 03, 2019
Public Version Number
1
DI Record Publish Date
November 25, 2019
Package DI Number
10015482983281
Quantity per Package
60
Contains DI Package
00015482983284
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |