NA

Basic Information

• Brand Name: NA
• Primary DI: 04546540434340
• Version / Model: 0306650000
• Catalog Number: 0306650000
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 196548481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-24
• Public Version: 3
• Public Version Date: 2021-03-10
• Public Version Status: Update
• Public Device Record Key: 41ce922a-b791-4c7b-81b3-96684333a936

Device Description

Percutaneous Cement Gun

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: Yes
• Has Lot/Batch Number: No
• 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
OAR	Injector, vertebroplasty (does not contain cement)	Orthopedic	888.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47703	Orthopaedic cement/bone filler dispensing gun	A hand-operated device designed to hold an orthopaedic cement/filler syringe/cartridge and to facilitate the dispensing of the substance to the application site or an application device. It is a pistol-like device with a barrel recess, to place the syringe/cartridge, which includes a trigger mechanism to force the substance from the distal end, and may include graduated markings to dispense the substance in discrete quantities. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04546540434340	GS1

Customer Contacts

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