Duns Number:081132841
Device Description: MicroCutter 30 Blue Reload is compatible with the MicroCutter 5/80 Stapler
Catalog Number
FG-025320
Brand Name
MicroCutter 30 Blue Reload
Version/Model Number
FG-025320
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K161137,K161137
Product Code
GDW
Product Code Name
Staple, Implantable
Public Device Record Key
98dbe315-16d7-4efa-9d2e-c9327948fe95
Public Version Date
May 07, 2019
Public Version Number
7
DI Record Publish Date
August 08, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |