ItsoClear

Basic Information

• Brand Name: ItsoClear
• Primary DI: H66810091511
• Version / Model: 1009151
• Catalog Number: 1009151
• Company Name: Keystone Industries
• Labeler DUNS: 073503117
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2022-11-30
• Public Version: 1
• Public Version Date: 2022-12-08
• Public Version Status: New
• Public Device Record Key: 78126dd0-47d2-471a-8596-5a2458c72917

Device Description

Clear Molar Clasps (1.8 mm) 6/pkg

Device Characteristics

• Single Use: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EHP	CLASP, PREFORMED	Dental	872.3285	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38625	Denture clasp, polymer, preformed	A prefabricated dental device made of polymer material intended to retain and stabilize a removable partial denture to stationary teeth. It is manufactured to meet a standard specification for adaptation or direct insertion into the patient's mouth.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	H66810091510	HIBCC
Primary	H66810091511	HIBCC

Customer Contacts

• Phone: [phone] ext. 8455
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	1.8	Millimeter