RC-Prep

Basic Information

• Brand Name: RC-Prep
• Primary DI: 00348783001228
• Version / Model: 9007135
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• Labeler DUNS: 014789663
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2023-06-13
• Public Version: 1
• Public Version Date: 2023-06-21
• Public Version Status: New
• Public Device Record Key: 04f71ce9-d0ec-43f9-9571-922adc8d94e0

Device Description

RC-Prep 9g Syringe box of 1 (Pack of 10) - China

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
EKQ	Preparer, Root Canal Endodontic	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45233	Endodontic reaming aid material	A liquid or gel substance typically used during root canal procedures as a chelating agent for chemical reaming to aid mechanical reaming, or as a lubricant to facilitate endodontic instrument penetration. It will typically have bactericidal properties. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00348783001211	GS1
Primary	00348783001228	GS1