GC CARTRIDGE DISPENSER II 152161

GUDID 10386040006149

GC CARTRIDGE DISPENSER II Plunger, 48mL

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: 10386040006149
• NIH Device Record Key: 688f41ff-1d7c-40a6-85dd-16f1893ae1f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GC CARTRIDGE DISPENSER II
• Version Model Number: 152161
• Catalog Number: 152161
• 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	10386040006149 [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: 2022-07-15
• Device Publish Date: 2022-07-07

On-Brand Devices [GC CARTRIDGE DISPENSER II]

• 10386040006156: GC CARTRIDGE DISPENSER II Plunger Conversion Kit, 75mL
• 10386040006149: GC CARTRIDGE DISPENSER II Plunger, 48mL
• 10386040006132: GC CARTRIDGE DISPENSER II 75mL
• 10386040004107: GC CARTRIDGE DISPENSER II 48mL