| Primary Device ID | 20686864022460 |
| NIH Device Record Key | 564dda7a-b9e6-4e50-b85a-d1ced4210d92 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MEDICOM DURAFLOR |
| Version Model Number | 10011-US |
| Catalog Number | 10011-US |
| Company DUNS | 256880576 |
| Company Name | AMD Medicom 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 | 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 |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca | |
| Phone | +1(514)636-6262 |
| amdudi@medicom.ca |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Total Volume | 10 Milliliter |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10686864022463 [Primary] |
| GS1 | 20686864022460 [Package] Contains: 10686864022463 Package: OUTER CASE [12 Units] In Commercial Distribution |
| LBH | VARNISH, CAVITY |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2022-04-19 |
| Device Publish Date | 2016-09-11 |
| 20686864041034 | DURAFLOR VARNISH 5% FLUORIDE SAMPLE PACK |
| 20686864020961 | DURAFLOR VARNISH 5% FLUORIDE RASPBERRY -DOSE |
| 20686864020954 | DURAFLOR VARNISH 5% FLUORIDE BUBBLE GUM -DOSE |
| 20686864022460 | DURAFLOR VARNISH 5% FLUORIDE BUBBLE GUM -TUBE |
| 20686864020930 | DURAFLOR VARNISH 5% FLUORIDE BUBBLE GUM -DOSE |
| 20686864020947 | DURAFLOR VARNISH 5% FLUORIDE RASPBERRY -DOSE |