Duns Number:942377524
Device Description: Integra® MemoFix® Staple SystemThe MemoFix tamp is used to push down the staple into the b Integra® MemoFix® Staple SystemThe MemoFix tamp is used to push down the staple into the bone.
Catalog Number
MS-2920
Brand Name
MemoFix® Super Elastic Nitinol Staple System
Version/Model Number
MS-2920
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HXG
Product Code Name
TAMP
Public Device Record Key
eea0d073-ee01-4dca-8482-9877be917bd4
Public Version Date
August 09, 2019
Public Version Number
3
DI Record Publish Date
September 05, 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 | 1909 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1404 |
| 3 | A medical device with high risk that requires premarket approval | 12 |
| U | Unclassified | 15 |