SURFIX®

Basic Information

• Brand Name: SURFIX®
• Primary DI: 10381780044659
• Version / Model: MA042ND
• Company Name: NEWDEAL
• Labeler DUNS: 536935331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-26
• Public Version: 3
• Public Version Date: 2023-02-06
• Public Version Status: Update
• Public Device Record Key: 74ecd6e2-3617-487f-b410-f3cc401872e6
• Distribution End Date: 2027-12-31

Device Description

The SURFIX® distractor allows opening at the correct angulation, maintaining this correction while filling up the gap and during the fixation of the SURFIX® plate for opening wedge osteotomy.

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: Yes
• 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: Yes
• 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
HTC	PLIERS, SURGICAL	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37529	Bone-angle protractor	A device intended to be used to measure the angles of bones, e.g., on x-rays or during surgery. It is commonly known as a protractor. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M248MA042ND1	HIBCC
Primary	10381780044659	GS1

Customer Contacts

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