WOODPECKER

Basic Information

• Brand Name: WOODPECKER
• Primary DI: 06944843604428
• Version / Model: WP5004
• Company Name: Guilin Woodpecker Medical Instrument Co., Ltd.
• Labeler DUNS: 545272577
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-17
• Public Version: 1
• Public Version Date: 2022-08-25
• Public Version Status: New
• Public Device Record Key: 32ee2652-3664-4546-982a-fe373dd9c57d

Device Description

Gutta-percha injector

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: No
• 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
EKR	Plugger, Root Canal, Endodontic	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44859	Gutta-percha injector	A hand-held, pistol-shaped, electrically-heated device used to deliver warmed and softened gutta-percha to the dental root canal. Sticks of gutta-percha are inserted into the device and thermally softened before being squeezed out with the ejection trigger through an application tube of varying sizes into the root canal. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06944843604428	GS1