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Whitney No-Scratch Valitome

FDA UDI

Class I (US FDA UDI)

by Whitney Medical Solutions

Identity

Trade Name
Whitney No-Scratch Valitome FDA UDI
Generic Name
Orthopaedic cement curette FDA UDI
Device Name
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. FDA UDI
Model / Reference
OR1205 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
OR1205 FDA UDI
Primary DI / UDI-DI
M266OR12050 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic cement curette FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 22 Millimeter FDA UDI
Width — 13 Millimeter FDA UDI

Category: Orthopaedic cement curette

Whitney No-Scratch Valitome by Whitney Medical Solutions — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic cement curette.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Whitney Medical Solutions

Sources (1)

  • FDA UDI bbbf9538-ef44-4225-9642-71bbfe1f9e7a 36 fields · synced May 30, 2026