RC-Prep

GUDID 00348783001129

RC-Prep 9g Syringe box of 2 (Pack of 10)

PREMIER DENTAL PRODUCTS COMPANY

Endodontic reaming aid material

• Primary Device ID: 00348783001129
• NIH Device Record Key: 6658da67-7d2d-4703-a4ce-0c7e5efba189
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RC-Prep
• Version Model Number: 9007135
• Company DUNS: 014789663
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00348783001129 [Unit of Use]
GS1	00348783001136 [Primary]

FDA Product Code

• EKQ: Preparer, Root Canal Endodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-21
• Device Publish Date: 2023-06-13

On-Brand Devices [RC-Prep]

• D6919007139: RC-PREP 3CC SYRINGE TIP REFILL (50)
• D6919007127: RC PREP PLASTIC 9G SYR TIP REFILL (50)
• 00348783000344: RC-Prep Syringe Kit - Five 3 cc syringes + 50 tips
• 00348783001235: RC-Prep 9g Syringe box of 2 - Russia
• 00348783001211: RC-Prep 9g Syringe box of 1 (Pack of 10) - China
• 00348783001167: RC-Prep 18g Jar (Pack of 10)
• 00348783001143: RC-Prep 18g Pump (Pack of 10)
• 00348783001129: RC-Prep 9g Syringe box of 2 (Pack of 10)
• 00348783000375: RC-Prep 227 g Jar
• 00348783005141: RC-PREP 3CC SYRINGE TIP REFILL (50)
• 00348783005134: RC PREP PLASTIC 9G SYR TIP REFILL (50)