GC Fuji II® 000103
GUDID 24548161294086
GC Fuji II® Dark Gray, 1-1 Pack (1 x 15 g powder and 1 x 8 mL liquid) 1 x mixing pad & 1 x measuring scoop
Gc America Inc.
Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement| Primary Device ID | 24548161294086 |
| NIH Device Record Key | 296ce723-26dd-400e-b285-cf6bca6f696c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GC Fuji II® |
| Version Model Number | 000103 |
| Catalog Number | 000103 |
| 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 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 4 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 39 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 14548161294089 [Primary] |
| GS1 | 24548161294086 [Package] Contains: 14548161294089 Package: Carton [5 Units] In Commercial Distribution |
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 | 2022-08-29 |
| Device Publish Date | 2022-08-19 |
On-Brand Devices [GC Fuji II®]
| 24548161329399 | GC Fuji II® FUJI II CAPSULE (50) ASSORTMENT |
| 24548161294086 | GC Fuji II® Dark Gray, 1-1 Pack (1 x 15 g powder and 1 x 8 mL liquid) 1 x mixing pad & 1 x meas |
| 24548161293973 | GC Fuji II® Pale Yellow, 1-1 Pack (1 x 15 g powder and 1 x 8 mL liquid) 1 mixing pad & 1 x meas |
| 24548161293751 | GC Fuji II® Dark Gray, 15 g powder |
| 24548161293713 | GC Fuji II® Pale Yellow, 15 g powder |
| 24548161283059 | GC Fuji II® 8 mL liquid |
| 24548161282922 | GC Fuji II® Yellow Brown, 15 g powder |
| 24548161282519 | GC Fuji II® Yellow Brown, 1-1 Pack (1 x 15 g powder and 1 x 8 mL liquid) 1 mixing pad & 1 x mea |
Trademark Results [GC Fuji II]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GC FUJI II 75784038 2397606 Live/Registered |
TRADEMARK HOLDINGS OF ILLINOIS LLC 1999-08-25 |
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