RC-Prep

GUDID D6919007139

RC-PREP 3CC SYRINGE TIP REFILL (50)

PREMIER DENTAL PRODUCTS COMPANY

Dental material injection cannula, single-use

• Primary Device ID: D6919007139
• NIH Device Record Key: 9515daa0-880e-409a-8d10-96fa26350a97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RC-Prep
• Version Model Number: 9007139
• Company DUNS: 014789663
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
HIBCC	D6919007139 [Primary]

FDA Product Code

• KXR: Applicator, Resin

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: 2022-07-07
• Device Publish Date: 2022-06-29

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)