Bosworth TruRepair

Basic Information

• Brand Name: Bosworth TruRepair
• Primary DI: H6680921691
• Version / Model: 092169
• Catalog Number: 092169
• Company Name: Harry J Bosworth Company
• Labeler DUNS: 014769301
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-26
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: ae8c5584-810f-4328-9af2-85808eed9a44

Device Description

5 lb Repair Pwd, Vein

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBI	RESIN, DENTURE, RELINING, REPAIRING, REBASING	Dental	872.3760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11171	Denture repair kit, professional	A collection of devices used in dentistry by a dentist or dental laboratory technician to repair cracks or breaks in a denture. It will contain the necessary materials and components, e.g., resins, adhesives/glues, mixing utensils, and an applicator. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	H6680921691	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	2.27	Kilogram
Weight	5	Pound

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from moisture
• Type: Special Storage Condition, Specify
• Special Conditions: Keep out of direct sunlight