EXCAVATOR DOUBLE ENDED

Basic Information

• Brand Name: EXCAVATOR DOUBLE ENDED
• Primary DI: J003B0095041042001
• Version / Model: B009504104200
• Catalog Number: B009504104200
• Company Name: MAILLEFER INSTRUMENTS HOLDING Sàrl
• Labeler DUNS: 480538495
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-30
• Public Version: 2
• Public Version Date: 2024-01-24
• Public Version Status: Update
• Public Device Record Key: 470dfa86-edef-4ed2-9096-637ac7966830
• Distribution End Date: 2023-06-30

Device Description

N/A

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKC	EXCAVATOR, DENTAL, OPERATIVE	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35811	Dental excavator, reusable	A hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J003B0095041042001	HIBCC

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: N/A