AccessGUDID - DEVICE: Whitney No-Scratch Valitome (M266OR12050)

GUDID

Device Identifier (DI) Information

Brand Name: Whitney No-Scratch Valitome
Version or Model: OR1205
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OR1205
Company Name: Whitney Medical Solutions

Primary DI Number: M266OR12050
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119676187 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47735	Orthopaedic cement curette	A sterile, hand-held, manual surgical instrument designed to remove excess orthopaedic bone cement from an implantation site during the cementing of a prosthesis. It is typically made of plastic materials and consists of a handle proximally and a concave, spoon-like tip that is angled at the distal end, or it may be double-ended with the handle placed centrally. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic Manual Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 22 Millimeter
Width: 13 Millimeter

Device Record Status

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