Brasseler USA

Basic Information

• Brand Name: Brasseler USA
• Primary DI: 00887919800804
• Version / Model: 5026400U0
• Company Name: Peter Brasseler Holdings, LLC
• Labeler DUNS: 082080136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-09
• Public Version: 1
• Public Version Date: 2022-12-19
• Public Version Status: New
• Public Device Record Key: a9c983fc-0a59-435c-a311-3d55ed205f7e

Device Description

ENDORING II E-FOAM INSERTS 60P

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Manufacturing Date: No
• 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
EIL	GAUGE, DEPTH, INSTRUMENT, DENTAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64815	Endodontic instrument-holding insert, single-use	A device intended to be fitted into an endodontic instrument holder housing and used chairside during a dental endodontic procedure to hold and temporarily store sharp endodontic instruments (e.g., files/rasps). It is in the form of a spongy foam insert into which the sharp end of instruments is inserted, thereby reducing risk of injury. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887919800804	GS1