Duns Number:080061451
Device Description: Sterile Lancets; Fine gauge 28G Tri-bevel tip Universal Design fits most lancing devices 1 Sterile Lancets; Fine gauge 28G Tri-bevel tip Universal Design fits most lancing devices 1 Box of 50pcs
Catalog Number
-
Brand Name
HEPRO.US Lancets MM1000
Version/Model Number
Box LANCETS 50pcs
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)
-
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
31633f30-cc8b-4f21-ae1a-dc57435022e7
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 20, 2017
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |