G7®

Basic Information

• Brand Name: G7®
• Primary DI: 00887868462450
• Version / Model: 110002771
• Catalog Number: 110002771
• Company Name: Biomet Orthopedics, LLC
• Labeler DUNS: 129278169
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-30
• Public Version: 1
• Public Version Date: 2021-05-10
• Public Version Status: New
• Public Device Record Key: 94e0e9f3-7857-43b6-a099-aab8a7e7dde0

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
OQH	Hip, semi-constrained, cemented, metal/polymer + additive, cemented	Orthopedic	888.3350	2
OQG	Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented	Orthopedic	888.3358	2
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	Orthopedic	888.3353	2
OQI	Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented	Orthopedic	888.3353	2
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED	Orthopedic	888.3358	2
PBI	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive	Orthopedic	888.3310	2
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer	Orthopedic	888.3310	2
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	Orthopedic	888.3350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44742	Joint prosthesis implantation kit, reusable	A collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887868462450	GS1

Customer Contacts

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