Duns Number:119676187
Device Description: No-Scratch ™ Whitney Valitome ™ is a single-use, sterile, plastic instrument, in the shape No-Scratch ™ Whitney Valitome ™ is a single-use, sterile, plastic instrument, in the shape of an osteotome, for quickly applying, manipulating, spreading, and removing bone cement during hip and knee replacement surgery. The plastic is softer than steel instruments, reducing the risk of damaging the prosthesis with metal instruments. The Valitome’s 12mm wide tip removes excess cement from replacement hips and knees, and can also be used to apply or spread cement. Easy-to-maneuver, the teal Valitome lets you remove cement from all edges of the prosthesis.No-Scratch Whitney Valitome Features:SAFER THAN STEEL- Made of plastic - sturdy yet softer than surgical steel.HANDIER- Each tool has a molded-in thumb indentation instantly orienting the tool.- Easier to maneuver in hard to see places.- Color-coded for easy identification.FASTER- Comes individually packaged in sterile, peel open pouch, ready to go.- Applies, manipulates, or removes cement with fingertip precision.ECONOMICAL- The cost of a single revision dwarfs the cost of a single-use instrument. - Disposable – there’s no need to waste time removing hardened cement or re-sterilizing tools.- Less expensive to buy and inventory - order only the tool you use.- Packaged 25 individually wrapped tools to a carton for convenient shelf storage.
Catalog Number
OR1205
Brand Name
Whitney No-Scratch Valitome
Version/Model Number
OR1205
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
bbbf9538-ef44-4225-9642-71bbfe1f9e7a
Public Version Date
February 07, 2019
Public Version Number
1
DI Record Publish Date
January 07, 2019
Package DI Number
M266OR12051
Quantity per Package
25
Contains DI Package
M266OR12050
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton of 25
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |