FILLER

Basic Information

• Brand Name: FILLER
• Primary DI: 00888118069740
• Version / Model: 44-380-06-07
• Company Name: KLS-Martin L.P.
• Labeler DUNS: 826499238
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-26
• Public Version: 4
• Public Version Date: 2019-08-23
• Public Version Status: Update
• Public Device Record Key: 193f48a1-947f-49ea-9ab0-e0cc82104bc4

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: 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
GAF	SPATULA, SURGICAL, GENERAL & PLASTIC SURGERY	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16460	Dental amalgam condenser, reusable	A hand-held manual dental instrument intended for packing amalgam or direct filling gold (Au). It may be smooth or serrated in design and flat or curved in shape. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888118069740	GS1

Customer Contacts

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