Duns Number:835465063
Device Description: PROSTHESIS 1156256 FLPL PLT PSTN .6X4.25
Catalog Number
-
Brand Name
NA
Version/Model Number
1156256
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 01, 2018
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
K872112
Product Code
ETB
Product Code Name
PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT
Public Device Record Key
6be39be1-b7b5-405e-8266-84501d200428
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
June 23, 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 |