152081

GUDID 10386040012393

PLUNGER FOR UNIVERSAL DISPENSER

Gc America Inc.

Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system

• Primary Device ID: 10386040012393
• NIH Device Record Key: e74c26a6-4254-4881-93a0-fe86c240779b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 152081
• Catalog Number: 152081
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10386040012393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955932

FDA Product Code

• ELW: MATERIAL, IMPRESSION

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: 2022-07-25
• Device Publish Date: 2022-07-15

Devices Manufactured by Gc America Inc.

• 10386040015264 - GC Fuji ORTHO™: 2024-03-21
• 10386040015271 - GC Fuji ORTHO™: 2024-03-21
• 10386040015288 - GC Fuji Ortho™: 2024-03-21
• 20386040015247 - Foundation: 2024-03-20 Collagen-Based Bone Filling Augmentation Material
• 20386040015254 - Foundation: 2024-03-20 Collagen-Based Bone Filling Augmentation Material
• 10386040015233 - GC Tooth Mousse: 2024-03-15 GC Tooth Mousse Plus
• D0470000631 - UniFil®: 2024-02-16 UniFil® 6 mL self-etching primer liquid
• D0470000641 - UniFil®: 2024-02-16 UniFil® 6 mL bonding agent liquid