Duns Number:137354267
Device Description: High Capacity Hip Revision Tip
Catalog Number
00-5150-184-00
Brand Name
PULSAVAC®
Version/Model Number
00-5150-184-00
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
FQH
Product Code Name
LAVAGE, JET
Public Device Record Key
4f0d3bae-ec30-4200-bf39-aebe3ca29482
Public Version Date
November 06, 2020
Public Version Number
4
DI Record Publish Date
November 07, 2017
Package DI Number
00889024379923
Quantity per Package
5
Contains DI Package
00889024374980
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1447 |
2 | A medical device with a moderate to high risk that requires special controls. | 96 |