MI Varnish 442500
GUDID 00386040010408
MI Varnish 50pc Pack Strawberry - US
Gc America Inc.
Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional| Primary Device ID | 00386040010408 |
| NIH Device Record Key | 2023f13f-967d-404e-9d6c-0572ae641ac3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MI Varnish |
| Version Model Number | 442500 |
| Catalog Number | 442500 |
| 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 | |
| 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 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 46 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 8 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00386040010408 [Unit of Use] |
| GS1 | 10386040010405 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K102808
FDA Product Code
| LBH | VARNISH, CAVITY |
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 | 2022-08-22 |
| Device Publish Date | 2022-08-12 |
On-Brand Devices [MI Varnish]
| 00386040010415 | MI Varnish 50 pc Pack Fresh Mint - US |
| 00386040010408 | MI Varnish 50pc Pack Strawberry - US |
Trademark Results [MI Varnish]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MI VARNISH 86318220 4905795 Live/Registered |
GC CORPORATION 2014-06-24 |
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