Dowell Dental Products, Inc

Basic Information

• Brand Name: Dowell Dental Products, Inc
• Primary DI: D961MS12800
• Version / Model: MS1280
• Company Name: Dowell Dental Products, Inc
• Labeler DUNS: 004041234
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-23
• Public Version: 1
• Public Version Date: 2022-08-31
• Public Version Status: New
• Public Device Record Key: 3e105623-cc77-46d3-8583-0f50cfe6ad17

Device Description

MICRO BLADE HOLDER

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
EMJ	Elevator, Surgical, Dental	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45145	Dental/maxillofacial surgical procedure kit, medicated, reusable	A collection of various dental/surgical instruments, dressings, pharmaceuticals and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D961MS12800	HIBCC

Customer Contacts

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