Duns Number:030849173
Device Description: FLUOROPLASTIC PISTON 0.3MM DIA X 6.00MM L
Catalog Number
-
Brand Name
FLUOROPLASTIC PISTON
Version/Model Number
400-600
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K060518
Product Code
ETB
Product Code Name
Prosthesis, Partial Ossicular Replacement
Public Device Record Key
354b20d6-43c6-42d6-a067-592fc1c8a121
Public Version Date
March 23, 2020
Public Version Number
4
DI Record Publish Date
November 21, 2017
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 | 200 |
2 | A medical device with a moderate to high risk that requires special controls. | 564 |