GC Fuji® 444003
GUDID 10386040012522
GCFuji® Automix LC Starter Set A3, Paste Pak Dispenser II, Cavity conditioner
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| Primary Device ID | 10386040012522 |
| NIH Device Record Key | 3fb833fe-0d00-4f94-9f96-df3c35f5a333 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GC Fuji® |
| Version Model Number | 444003 |
| Catalog Number | 444003 |
| 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 |
Device Dimensions
| Total Volume | 7.2 Milliliter |
| Total Volume | 7.2 Milliliter |
| Total Volume | 7.2 Milliliter |
| Total Volume | 7.2 Milliliter |
| Total Volume | 7.2 Milliliter |
| Total Volume | 7.2 Milliliter |
| Total Volume | 7.2 Milliliter |
| Total Volume | 7.2 Milliliter |
| Total Volume | 7.2 Milliliter |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10386040012522 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K172382
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 | 2022-07-25 |
| Device Publish Date | 2022-07-15 |
On-Brand Devices [GC Fuji®]
| 10386040012522 | GCFuji® Automix LC Starter Set A3, Paste Pak Dispenser II, Cavity conditioner |
| 10386040012515 | GC Fuji® Automix LC Starter Set A2, Paste Pak Dispenser II, Cavity conditioner |
| 10386040012508 | GC Fuji® Automix LC Starter Set A1, Paste Pak Dispenser II, Cavity conditioner |
| 14548161321983 | GC Fuji® Automix LC Set - Cartridge A3 shade + 20 Automix tips |
| 14548161321976 | GC Fuji® Automix LC Set - Cartridge A2 shade + 20 Automix tips |
| 14548161321969 | GC Fuji® Automix LC Set- Cartridge A1 shade + 20 Automix tips |
Trademark Results [GC Fuji]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GC FUJI 86353566 4699637 Live/Registered |
Trademark Holdings of Illinois LLC 2014-07-31 |
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