Duns Number:081277700
Device Description: Composite, 4, GTX, Double-Ended, Black-Green, Tactile Tone™
Catalog Number
TD4X-KG
Brand Name
Integra® Miltex®
Version/Model Number
TD4X-KG
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2020
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
EKF
Product Code Name
INSTRUMENT, CONTOURING, MATRIX, OPERATIVE
Public Device Record Key
cfa387a8-3f8d-4c7b-a03b-09c8c2794297
Public Version Date
November 02, 2020
Public Version Number
5
DI Record Publish Date
April 19, 2018
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 | 15051 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4286 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |