MCCALL CURETTE

Basic Information

• Brand Name: MCCALL CURETTE
• Primary DI: 00192896082403
• Version / Model: 1102-SCMC17-18
• Catalog Number: 1102-SCMC17-18
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-21
• Public Version: 4
• Public Version Date: 2023-07-19
• Public Version Status: Update
• Public Device Record Key: 022e7cb0-ff85-455a-b933-ea96af38c1e8
• Distribution End Date: 2023-07-18

Device Description

MCCALL CURETTE #17-18 DOUBLE ENDED BLADES

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", "Dry Heat Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EMK	CURETTE, SURGICAL, DENTAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41660	Periodontal curette	A hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is made of metal. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896082403	GS1

Customer Contacts

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