MI Paste™ 422265
GUDID 20386040008584
MI Paste™ 10-pack, 10 tubes (40g each) of MI Paste Assorted has 2 tubes of each flavor (melon, mint, strawberry, tutti-frutti & vanilla)
Gc America Inc.
Dental coating, tooth-desensitizing, professional| Primary Device ID | 20386040008584 |
| NIH Device Record Key | 7c71ade7-d7aa-4c7a-8d13-e5165d4cf082 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MI Paste™ |
| Version Model Number | 422265 |
| Catalog Number | 422265 |
| 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 |
Operating and Storage Conditions
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10386040008587 [Primary] |
| GS1 | 20386040008584 [Package] Contains: 10386040008587 Package: [30 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042200
FDA Product Code
| EJR | AGENT, POLISHING, ABRASIVE, ORAL 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 | 2022-07-21 |
| Device Publish Date | 2022-07-13 |
On-Brand Devices [MI Paste™]
| 20386040008706 | MI Paste™ 10-pack, 10 tubes (40g each) Strawberry only |
| 20386040008676 | MI Paste™ 10 tubes (40g each) Mint only |
| 20386040008584 | MI Paste™ 10-pack, 10 tubes (40g each) of MI Paste Assorted has 2 tubes of each flavor (melon, |
Trademark Results [MI Paste]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MI PASTE 77084552 3531617 Live/Registered |
GC Corporation 2007-01-17 |
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