Duns Number:679894738
Device Description: Gentleheel Devices are made of lower housing, upper housing, spring, blade, spring holder, Gentleheel Devices are made of lower housing, upper housing, spring, blade, spring holder, blade holder, safety lock, button, etc. Materials of all components and package are medical grade and match the requirement of medical use. The products are EO sterilized.
Catalog Number
-
Brand Name
GRI
Version/Model Number
GHN10X50
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"
Yes
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
da9aa386-adad-4069-a377-d8a6034e5a48
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 29, 2016
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 | 185 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 295 |