Duns Number:942377524
Device Description: Integra® MemoFix® Staple SystemThe MemoFix Staple Instrument Tray contains instruments use Integra® MemoFix® Staple SystemThe MemoFix Staple Instrument Tray contains instruments used to aid in the implantation of the MemoFix Staples.
Catalog Number
STAPLEINST
Brand Name
MemoFix® Super Elastic Nitinol Staple System
Version/Model Number
STAPLEINST
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
FZX
Product Code Name
Guide, surgical, instrument
Public Device Record Key
26d094aa-585d-45c6-b905-57e526b90f1b
Public Version Date
September 16, 2022
Public Version Number
8
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 |