Duns Number:042763706
Device Description: INFINITY EXTERNAL 3.3X11.5MM Ø3.5MM HD HEX IMPLANT TI CP GRADE 4
Catalog Number
403311
Brand Name
Infinity External Hex Implant System
Version/Model Number
403311
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
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
K954513
Product Code
DZE
Product Code Name
IMPLANT, ENDOSSEOUS, ROOT-FORM
Public Device Record Key
1a941223-501d-4e28-a91c-50c2f85bb1e4
Public Version Date
November 08, 2019
Public Version Number
5
DI Record Publish Date
October 24, 2015
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 | 1288 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 943 |
| U | Unclassified | 6 |