PADDLE/CONDENSER

Basic Information

• Brand Name: PADDLE/CONDENSER
• Primary DI: 00192896088023
• Version / Model: 1102-REPFI3T
• Catalog Number: 1102-REPFI3T
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-17
• Public Version: 5
• Public Version Date: 2019-09-06
• Public Version Status: Update
• Public Device Record Key: 85088b42-3f3a-4edb-a577-57e6fa9ea89c

Device Description

PADDLE/CONDENSER #3T DOUBLE ENDED FLARED/FLAT BLADES LIGHT HANDLE TITANIUM

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: ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKG	CONDENSER, AMALGAM AND FOIL, OPERATIVE	Dental	872.4565	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	00192896088023	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1.1 Millimeter Blade
Device Size Text, specify			7 x 2 Millimeter Tip