NA

Basic Information

• Brand Name: NA
• Primary DI: 10886982071422
• Version / Model: 03.100.358
• Catalog Number: 03100358
• Company Name: Synthes GmbH
• Labeler DUNS: 486711679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-31
• Public Version: 3
• Public Version Date: 2022-04-28
• Public Version Status: Update
• Public Device Record Key: 3104f0cd-58e9-4c6b-8584-b0dc6451821e

Device Description

FEMORAL HEAD TEMPLATE 58MM DIAMETER

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
HWT	TEMPLATE	Orthopedic	888.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58772	Femoral head sphericity template	A non-sterile hand-held manual gauge intended to be used to help estimate the loss of sphericity of the femoral head to help guide femoral head restoration during an osteoplasty procedure [e.g., an osteotomy to correct femoro-acetabular impingement (FAI)]. It is typically made of plastic and includes a handle attached to a transparent, semi-spherical concave base applied to the femoral head for the estimation; it is available as a set of graduated sizes. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	07611819483484	GS1
Secondary	H679031003580	HIBCC
Primary	10886982071422	GS1

Customer Contacts

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