Duns Number:003080678
Device Description: OneStep+ Lancet 1.8mm Grey 100/PK
Catalog Number
592011
Brand Name
Hopkins Medical Products®
Version/Model Number
592011
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
K101145
Product Code
FMK
Product Code Name
Lancet, blood
Public Device Record Key
a4c8b4b5-cadd-4b87-95e6-fc720ab1c9bf
Public Version Date
October 29, 2018
Public Version Number
1
DI Record Publish Date
September 28, 2018
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 96 |
2 | A medical device with a moderate to high risk that requires special controls. | 135 |