Newport Surgical

Basic Information

• Brand Name: Newport Surgical
• Primary DI: D74570BIOIBGKIT0
• Version / Model: 70-BIO-IBGKIT
• Catalog Number: 70-BIO-IBGKIT
• Company Name: Prismatik Dentalcraft, Inc
• Labeler DUNS: 022761689
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-13
• Public Version: 2
• Public Version Date: 2023-08-22
• Public Version Status: Update
• Public Device Record Key: 2a986136-a1d9-4b84-b007-7749b6210e42

Device Description

Newport Surgical Implant and Bone Grafting Instrument Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDP	Accessories, implant, dental, endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45147	Dental/maxillofacial surgical procedure kit, non-medicated, reusable	A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D74570BIOIBGKIT0	HIBCC

Customer Contacts

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