| Primary Device ID | 20686864041027 |
| NIH Device Record Key | 4598639e-e466-4eee-a1e2-d35e7b43974f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MEDICOM DURAFLOR ULTRA |
| Version Model Number | SP-1016 |
| Catalog Number | SP-1016 |
| Company DUNS | 256880576 |
| Company Name | AMD Medicom Inc |
| Device Count | 3 |
| 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 | true |
| 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 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 |
| mkansou@medicom.ca |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Total Volume | 0.4 Milliliter |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Storage Environment Temperature | Between 15 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 82 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00686864041023 [Unit of Use] |
| GS1 | 20686864041027 [Primary] |
| 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 | 2020-01-09 |
| Device Publish Date | 2016-09-15 |
| 20686864041027 | DURAFLOR ULTRA VARNISH 5% FLUORIDE SAMPLE PACK -DOSE |
| 20686864041010 | DURAFLOR ULTRA VARNISH 5% FLUORIDE STRAWBERRY -DOSE |
| 20686864041003 | DURAFLOR ULTRA VARNISH 5% FLUORIDE CARAMEL -DOSE |
| 20686864040990 | DURAFLOR ULTRA VARNISH 5% FLUORIDE MINT -DOSE |
| 20686864040983 | DURAFLOR ULTRA VARNISH 5% FLUORIDE STRAWBERRY -DOSE |
| 20686864040976 | DURAFLOR ULTRA VARNISH 5% FLUORIDE CARAMEL -DOSE |
| 20686864040969 | DURAFLOR ULTRA VARNISH 5% FLUORIDE MINT -DOSE |
| 10686864056536 | DURAFLOR ULTRA VARNISH 5% FLUORIDE BUBBLE GUM - DOSE |
| 20686864056526 | DURAFLOR ULTRA VARNISH 5% FLUORIDE BUBBLE GUM - DOSE |
| 10686864056512 | DURAFLOR ULTRA VARNISH 5% FLUORIDE CHERRY - DOSE |
| 10686864056505 | DURAFLOR ULTRA VARNISH 5% FLUORIDE CHERRY - DOSE |
| 20686864056717 | DURAFLOR ULTRA VARNISH 5% FLUORIDE Sample Pack - 1 unit dose each (Bubble Gum & Cherry) |
| 20686864055901 | DURAFLOR ULTRA VARNISH 5% FLUORIDE ASSORTED FLAVORS - 400 units (MINT - 00686864040996 - 200 un |