Duns Number:008162518
Device Description: Samii Micro Knife 9" ang 2x5.5mm
Catalog Number
gS 33.1960
Brand Name
gSource
Version/Model Number
gS 33.1960
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
-
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
HTS
Product Code Name
Knife, Orthopedic
Public Device Record Key
0f9dab46-6aaa-4d4e-8adc-38686805fde2
Public Version Date
August 31, 2022
Public Version Number
2
DI Record Publish Date
July 08, 2021
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 | 4617 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 280 |