GC Fuji TRIAGE® 013605

GUDID D0470136050

Fuji TRIAGE EP CAPSULE (50 pcs) WHITE

Gc America Inc.

Dental coating, tooth-desensitizing, home-use

• Primary Device ID: D0470136050
• NIH Device Record Key: 49ea1ae6-dedd-4dde-9318-014299f6119a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GC Fuji TRIAGE®
• Version Model Number: 013605
• Catalog Number: 013605
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 50
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0470136050 [Unit of Use]
HIBCC	D0470136051 [Primary]

FDA Product Code

• EMA: CEMENT, DENTAL

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: 2021-07-29
• Device Publish Date: 2021-07-21

On-Brand Devices [GC Fuji TRIAGE®]

• D0470136050: Fuji TRIAGE EP CAPSULE (50 pcs) WHITE
• D0470136040: Fuji TRIAGE EP CAPSULE (50 pcs) PINK
• 00386040009914: GC Fuji TRIAGE® Starter Package, White (1 x 50 capsule package, 1 x Capsule Applier, 1 x GC CAV
• 00386040009907: GC Fuji TRIAGE® Starter Package, Pink (1 x 50 capsule package, 1 x Capsule Applier, 1 x GC CAVI
• 04548161077999: GC Fuji TRIAGE® White, box of 50 capsules
• 04548161077555: GC Fuji TRIAGE® Pink, box of 50 capsules
• 04548161332098: Fuji TRIAGE EP CAPSULE (50 pcs) WHITE
• 04548161332081: Fuji TRIAGE EP CAPSULE (50 pcs) PINK