GC Fuji LINING™ 000128
GUDID 24548161294307
GC Fuji LINING™ LC 6.8 mL liquid btl.
Gc America Inc.
Glass ionomer dental cement| Primary Device ID | 24548161294307 |
| NIH Device Record Key | 0015a295-f8e8-4a67-b726-0ed5ae579b8d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GC Fuji LINING™ |
| Version Model Number | 000128 |
| Catalog Number | 000128 |
| 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 |
Device Dimensions
| Total Volume | 6.8 Milliliter |
| Total Volume | 6.8 Milliliter |
| Total Volume | 6.8 Milliliter |
| Total Volume | 6.8 Milliliter |
| Total Volume | 6.8 Milliliter |
| Total Volume | 6.8 Milliliter |
| Total Volume | 6.8 Milliliter |
| Total Volume | 6.8 Milliliter |
| Total Volume | 6.8 Milliliter |
| Total Volume | 6.8 Milliliter |
| Total Volume | 6.8 Milliliter |
| Total Volume | 6.8 Milliliter |
| Total Volume | 6.8 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 |
| 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 | 14548161294300 [Primary] |
| GS1 | 24548161294307 [Package] Contains: 14548161294300 Package: Carton [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K901999
FDA Product Code
| EJK | LINER, CAVITY, CALCIUM HYDROXIDE |
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 LINING™]
| 10386040009201 | GC Fuji LINING™LC (Paste Pak) Starter Package (1 x 7g (7.2mL) Cartridge, 1 x GC Paste Pak Disp |
| 14548161077545 | GC Fuji LINING™ (1 x 7 g (4.7 mL) cartridge, 1 x mixing pad) |
| 24548161294307 | GC Fuji LINING™ LC 6.8 mL liquid btl. |
| 24548161293607 | GC Fuji LINING™ 10 g powder |
| 24548161282830 | GC Fuji LINING™ Intro Package, 1-1 Pack (1 x 10 g powder, 1 x 6.8 mL liquid & accessories) |
Trademark Results [GC Fuji LINING]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GC FUJI LINING 74092022 1995800 Live/Registered |
TRADEMARK HOLDINGS OF ILLINOIS LLC 1990-08-28 |
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