EXA Advanced 138113
GUDID 00386040013447
EXA Advanced Injection Fast Value Pack
Gc America Inc.
Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material| Primary Device ID | 00386040013447 |
| NIH Device Record Key | bb7dc304-3668-4b67-9e14-c764349e2a7a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXA Advanced |
| Version Model Number | 138113 |
| Catalog Number | 138113 |
| Company DUNS | 005473608 |
| Company Name | Gc America Inc. |
| Device Count | 8 |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00386040013447 [Unit of Use] |
| GS1 | 10386040013444 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K955932
FDA Product Code
| ELW | MATERIAL, IMPRESSION |
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 [EXA Advanced]
| 00386040013485 | EXA Advanced Injection Normal Value Pack |
| 00386040013478 | EXA Advanced Mono Normal Value Pack |
| 00386040013461 | EXA Advanced Regular Normal Value Pack |
| 00386040013454 | EXA Advanced Heavy Normal Value Pack |
| 00386040013447 | EXA Advanced Injection Fast Value Pack |
| 00386040013430 | EXA Advanced Mono Fast Set Value Pack |
| 00386040013423 | EXA Advanced Regular Fast Set Value Pack |
| 00386040013416 | EXA Advanced Heavy Fast Set Value Pack |
| 00386040013348 | EXA Advanced Inject 2 Pak w/Mixing Tips |
| 00386040013331 | EXA Advanced Mono 2 Pak w/Mixing Tips |
| 00386040013324 | EXA Advanced Regular 2 Pak w/Mixing Tips |
| 00386040013317 | EXA Advanced Heavy 2 Pak w/Mixing Tips |
| 00386040013294 | EXA Advanced Mono Fast 2 Pak w/Tips |
| 00386040013287 | EXA Advanced Reg Fast 2 Pak w/Tips |
| 00386040013270 | EXA Advanced Heavy Fast 2 Pak w/Tips |
Trademark Results [EXA Advanced]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXA ADVANCED 79308167 not registered Live/Pending |
GC Corporation 2021-02-15 |
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