AccessGUDID - DEVICE: Whitney No-Scratch Sculps Knife (M266OR12030)

GUDID

Device Identifier (DI) Information

Brand Name: Whitney No-Scratch Sculps Knife
Version or Model: OR1203
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OR1203
Company Name: Whitney Medical Solutions

Primary DI Number: M266OR12030
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 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.

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
Width: 14 Millimeter
Length: 20 Millimeter

Device Record Status

Public Device Record Key: 2318b923-88fc-4a28-9b2d-9ad48b5db908
Public Version Date: February 07, 2019
Public Version Number: 1
DI Record Publish Date: January 07, 2019