ZOLL-DENTAL

Basic Information

• Brand Name: ZOLL-DENTAL
• Primary DI: 00840105220329
• Version / Model: Z-7201
• Company Name: Zoll-Dental
• Labeler DUNS: 005449822
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-10
• Public Version: 4
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: db11e900-1d71-40b7-a548-7802da6d01de

Device Description

Bone Well

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
MXP	BONE PARTICLE COLLECTOR	Ear, Nose, Throat	874.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42893	General-purpose bowl, reusable	A portable bowl or basin designed to be used for a variety of medical purposes such as containing fluids, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter. The design and shape can vary including round, oblong, deep or quite shallow. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840105220329	GS1

Customer Contacts

• Phone: [phone] ext. 505
• Email: [email protected]