NA

Basic Information

• Brand Name: NA
• Primary DI: 10887587001531
• Version / Model: SD300.011
• Catalog Number: SD300011
• Company Name: SYNTHES (U.S.A.) LP
• Labeler DUNS: 832637081
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-31
• Public Version: 7
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: 613512d3-f511-4ecc-9678-8fe758895e6b
• Distribution End Date: 2020-06-28

Device Description

RADEL CUTTING BOARD

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
58387	Surgical cutting/shaping board, reusable	A stiff, plastic device intended to be used as a surface to trim/contour objects or tissues (e.g., implants, transplants) in an operating room (OR) or other clean room during a surgical procedure. It may be flat or contoured and/or have measurement graduations as a visual approximation aid. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H980SD3000110	HIBCC
Primary	10887587001531	GS1

Customer Contacts

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