Duns Number:030849173
Device Description: FEATHERVAC DISPOSABLE STAPES SEAT
Catalog Number
-
Brand Name
FEATHERVAC DISPOSABLE STAPES SEAT
Version/Model Number
906-002
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
-
Product Code
LRC
Product Code Name
Instrument, Ent Manual Surgical
Public Device Record Key
f32e6847-d5e4-499a-b78f-81bf70e36bf6
Public Version Date
January 18, 2021
Public Version Number
2
DI Record Publish Date
September 21, 2018
Package DI Number
10844505007129
Quantity per Package
5
Contains DI Package
00844505007122
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |