Duns Number:942377524
Device Description: Integra® MemoFix® Staple SystemThe MemoFix Staple Lid is the top part of the sterilization Integra® MemoFix® Staple SystemThe MemoFix Staple Lid is the top part of the sterilization tray which locks onto the base and keeps content inside the base.
Catalog Number
MT-4000L
Brand Name
MemoFix® Super Elastic Nitinol Staple System
Version/Model Number
MT-4000L
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
OJH
Product Code Name
Orthopedic tray
Public Device Record Key
175523f8-ef6b-439d-8913-847cee256d14
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 |