CEMENT SCULPS

Basic Information

• Brand Name: CEMENT SCULPS
• Primary DI: 00880304370548
• Version / Model: 416100
• Catalog Number: 416100
• Company Name: Biomet Orthopedics, LLC
• Labeler DUNS: 129278169
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2020-06-30
• Public Version: 1
• Public Version Date: 2020-07-08
• Public Version Status: New
• Public Device Record Key: 5957d5e5-3091-4e7f-b8b0-a75687189642

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44597	Orthopaedic cement extractor, manual	A hand-held manual surgical instrument designed to extract orthopaedic (bone) cement from a site of previous application during an orthopaedic surgical procedure to replace a previously cemented prosthesis. This GMDN code may include slide hammers, chisels, or other manually-operated devices which are intended to be used to break up the bone cement for removal. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	70880304370547	GS1
Primary	00880304370548	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]