SCOTT'S DISPOSABLE P/A 100/box SOFT CUP

Basic Information

• Brand Name: SCOTT'S DISPOSABLE P/A 100/box SOFT CUP
• Primary DI: D77824530031
• Version / Model: 245-3003
• Catalog Number: 245-3003
• Company Name: SCOTT'S DENTAL SUPPLY L.L.C.
• Labeler DUNS: 137217043
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2021-02-27
• Public Version: 1
• Public Version Date: 2021-03-08
• Public Version Status: New
• Public Device Record Key: 3ae120ad-0d20-42bf-bc92-c310ac7abe17

Device Description

SCOTT'S DISPOSABLE P/A 100/box SOFT CUP

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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
EHK	CUP, PROPHYLAXIS	Dental	872.6290	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46938	Dental polishing cup, single-use	A rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. 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	D77824530030	HIBCC
Primary	D77824530031	HIBCC

Customer Contacts

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