Duns Number:008965063
Device Description: Walgreens Extra Fine 33 Gauge Lancets Compatible with Delica®
Catalog Number
-
Brand Name
Walgreens
Version/Model Number
105728
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
22bee62c-6b5d-4bac-b79c-68e83e0f3c59
Public Version Date
October 16, 2020
Public Version Number
1
DI Record Publish Date
October 08, 2020
Package DI Number
10311917217083
Quantity per Package
24
Contains DI Package
00311917217086
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 | 75 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 74 |
| U | Unclassified | 2 |