Duns Number:081132841
Device Description: MicroCutter 30 Curved Tip Blue Reload is compatible with the MicroCutter 5/80 Stapler
Catalog Number
FG-025321
Brand Name
MicroCutter 30 Curved Tip Blue Reload
Version/Model Number
FG-025321
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
f574586a-40b3-4b92-af75-75439118ba87
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 |