GC Fuji TRIAGE® 439991
GUDID 00386040009914
GC Fuji TRIAGE® Starter Package, White (1 x 50 capsule package, 1 x Capsule Applier, 1 x GC CAVITY CONDITIONER, 1 x GC Fuji COAT LC)
Gc America Inc.
Dental coating, tooth-desensitizing, professional| Primary Device ID | 00386040009914 |
| NIH Device Record Key | 3285803d-6bcb-4541-a363-3acde3295274 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GC Fuji TRIAGE® |
| Version Model Number | 439991 |
| Catalog Number | 439991 |
| 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00386040009914 [Unit of Use] |
| GS1 | 10386040009911 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K013198
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 | 2022-07-21 |
| Device Publish Date | 2022-07-13 |
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 |
Trademark Results [GC Fuji TRIAGE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GC FUJI TRIAGE 78129241 2821756 Live/Registered |
TRADEMARK HOLDINGS OF ILLINOIS LLC 2002-05-16 |
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