Duns Number:007198742
Device Description: "70145843 DORNHOFFER HAPEX MALLEABLE TOR"
Catalog Number
-
Brand Name
DORNHOFFER HAPEX MALLEABLE TORP
Version/Model Number
70145843
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 04, 2018
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
-
Product Code
ETA
Product Code Name
REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
Public Device Record Key
ac622c74-a20c-4c5e-b2c6-377fe6cd2ac7
Public Version Date
October 06, 2022
Public Version Number
4
DI Record Publish Date
October 12, 2016
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 | 899 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 4 |