SCOTT'S SELECT HEDSTROM FILES 6/pk 25mm # 80

Basic Information

• Brand Name: SCOTT'S SELECT HEDSTROM FILES 6/pk 25mm # 80
• Primary DI: D77811245801
• Version / Model: 112-4580
• Catalog Number: 112-4580
• Company Name: SCOTT'S DENTAL SUPPLY L.L.C.
• Labeler DUNS: 137217043
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2021-02-27
• Public Version: 1
• Public Version Date: 2021-03-08
• Public Version Status: New
• Public Device Record Key: d3cc8c6e-ed24-44f0-8ec2-862e20c196e6

Device Description

ENDODONTIC H-FILES (6/pack) Length: 25mm, Size: 80, Material: Stainless Steel; For more information: https://www.scottsdental.com/catalog/product/view/id/23541/s/hedstrom-files-25mm-scott-s-select/

Device Characteristics

• Single Use: Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
EKS	FILE, PULP CANAL, ENDODONTIC	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63550	Rotary/reciprocating endodontic file/rasp, single-use	A dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D77811245800	HIBCC
Primary	D77811245801	HIBCC

Customer Contacts

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