ZOLL-DENTAL

Basic Information

• Brand Name: ZOLL-DENTAL
• Primary DI: 00840105220596
• Version / Model: Z-8007
• Company Name: Zoll-Dental
• Labeler DUNS: 005449822
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-10
• Public Version: 4
• Public Version Date: 2024-06-25
• Public Version Status: Update
• Public Device Record Key: 593fe5fc-5e3a-4687-a46d-7b2179f0e05d
• Distribution End Date: 2024-06-24

Device Description

Rongeur, Bohler Double-Action Angled 15cm

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
HTX	RONGEUR	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15713	Dental rongeur	A strongly constructed dental instrument that is used in the removal of the sharp edges of the alveolar crest of the bone following tooth extraction. It has a forceps or pliers-like design terminating at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws that bite (cut) through the bone tissue. It is made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840105220596	GS1

Customer Contacts

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