Duns Number:835465063
Device Description: PROSTHESIS 0300 H/A TOTAL 4MM HD 7MM L
Catalog Number
-
Brand Name
NA
Version/Model Number
0300
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K885201
Product Code
ETA
Product Code Name
REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
Public Device Record Key
ae32fafc-80f0-424f-90e3-2f7deb0aedbb
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 15, 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 | 665 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1575 |
| 3 | A medical device with high risk that requires premarket approval | 6 |
| U | Unclassified | 10 |