Bosworth

Basic Information

• Brand Name: Bosworth
• Primary DI: H66809214801
• Version / Model: 0921480
• Catalog Number: 0921480
• Company Name: Keystone Industries
• Labeler DUNS: 073503117
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2022-11-30
• Public Version: 2
• Public Version Date: 2024-02-05
• Public Version Status: Update
• Public Device Record Key: b37f8af9-57c9-477e-bb4d-f33f1563f1f0

Device Description

WONDER WEDGES (100)12MM Small BLUE

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: No
• 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
DZN	INSTRUMENTS, DENTAL HAND	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45007	Dental wedge, single-use	A small, dental device intended to be introduced between two adjacent teeth for slight separation during a dental procedure. It is typically used during the placement of a filling material, or to stabilize and support other devices (e.g., a matrix band and/or rubber dam). It may include a removable shield intended to protect the healthy tooth/teeth from damage by the instruments. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	H66809214800	HIBCC
Primary	H66809214801	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	12	Millimeter