Identity
- Trade Name
- Whitney No-Scratch Sculps Knife FDA UDI
- Generic Name
- Orthopaedic cement curette FDA UDI
- Device Name
- No-Scratch ™ Whitney Sculps Knife ™ is a single-use, plastic instrument for quickly applying, manipulating 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 Sculps Knife’s 14x20 mm tip removes excess cement from replacement hips and knees. Easy-to-maneuver, the green Sculps Knife lets you remove cement from all edges of the prosthesis. No-Scratch Whitney Sculps Knife 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 like the Sculps Knife. - 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
- OR1203 FDA UDI
- Description
- No-Scratch ™ Whitney Sculps Knife ™ is a single-use, plastic instrument for quickly applying, manipulating 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 Sculps Knife’s 14x20 mm tip removes excess cement from replacement hips and knees. Easy-to-maneuver, the green Sculps Knife lets you remove cement from all edges of the prosthesis. No-Scratch Whitney Sculps Knife 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 like the Sculps Knife. - 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
- OR1203 FDA UDI
- Primary DI / UDI-DI
- M266OR12030 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
- Width — 14 Millimeter FDA UDILength — 20 Millimeter FDA UDI
Category: Orthopaedic cement curette
Whitney No-Scratch Sculps Knife by Whitney Medical Solutions — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Whitney Medical Solutions
Sources (1)
- FDA UDI 2318b923-88fc-4a28-9b2d-9ad48b5db908 36 fields · synced Jun 1, 2026