Duns Number:151810868
Device Description: Rite Aid TRUEplus lancets
Catalog Number
S1066LB28-100
Brand Name
TRUEplus
Version/Model Number
Rite Aid TRUEplus Lancets
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
306d580b-08ef-467f-91ab-6ec4c222eff7
Public Version Date
November 04, 2020
Public Version Number
1
DI Record Publish Date
October 27, 2020
Package DI Number
10011822741108
Quantity per Package
24
Contains DI Package
00011822741101
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 | 25 |
2 | A medical device with a moderate to high risk that requires special controls. | 22 |