Britedent

Basic Information

• Brand Name: Britedent
• Primary DI: D974BSI01031
• Version / Model: BSI-0103
• Company Name: Bright Supply, Inc.
• Labeler DUNS: 124117012
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-31
• Public Version: 1
• Public Version Date: 2021-08-09
• Public Version Status: New
• Public Device Record Key: fa84f4f9-8b73-4472-bcff-29c0829e3399

Device Description

Barrier Film Pink

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• 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
IWX	Barrier, Control Panel, X-Ray, Movable	Radiology	892.6500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47082	Instrument/equipment drape dispenser	A device intended to be used to dispense sterile packs of instrument/equipment drapes that are normally sterile and used as a protective covering for various surgical and/or non-surgical instruments/equipment [e.g., a surgical or endoscopic tray, an operating room (OR) equipment table, an endoscope and endoscopic instruments]. This device typically holds a stack of drape/liner packs that are placed flat, one on top of the other, so that a user can remove a pack when required. This device is typically wall-mounted and can be made of metal and/or plastic materials.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D974BSI01032	HIBCC	Box	8	In Commercial Distribution
Primary	D974BSI01031	HIBCC