| Primary Device ID | 00686864060383 | 
| NIH Device Record Key | b3994dc4-0b92-4bf7-8bd9-198c32d58a10 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | HEDY DENTAL DAM | 
| Version Model Number | 310DG-6H | 
| Catalog Number | 310DG-6H | 
| Company DUNS | 256880576 | 
| Company Name | AMD Medicom Inc | 
| Device Count | 36 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| 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 | true | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | true | 
| 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 | |
| Phone | +1(514)636-6262 | 
| mkansou@medicom.ca | |
| Phone | +1(514)636-6262 | 
| mkansou@medicom.ca | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00686864060383 [Unit of Use] | 
| GS1 | 10686864060380 [Primary] | 
| EIE | Dam, Rubber | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-09-04 | 
| Device Publish Date | 2024-08-27 | 
| 00686864060444 | HEDY Polyisoprene Dental Dam - Non-Latex - 6" x 6" - Medium - Blue | 
| 00686864060437 | HEDY Polyisoprene Dental Dam - Non-Latex - 6" x 6" - Heavy - Blue | 
| 00686864060420 | HEDY Polyisoprene Dental Dam - Non-Latex - 5"x 5" - Medium - Blue | 
| 00686864060413 | HEDY Polyisoprene Dental Dam - Non-Latex - 5"x 5" - Heavy - Blue | 
| 00686864060406 | HEDY DENTAL DAM - Natural Rubber Latex - 6" x 6" - Thin - Green | 
| 00686864060390 | HEDY DENTAL DAM - Natural Rubber Latex - 6" x 6" - Medium - Green | 
| 00686864060383 | HEDY DENTAL DAM - Natural Rubber Latex - 6" x 6" - Heavy - Green | 
| 00686864060376 | HEDY DENTAL DAM - Natural Rubber Latex - 5" x 5" - Thin - Green | 
| 00686864060369 | HEDY DENTAL DAM - Natural Rubber Latex - 5" x 5" - Medium - Green | 
| 00686864060352 | HEDY DENTAL DAM - Natural Rubber Latex - 5" x 5" - Heavy - Green | 
| 00686864060345 | HEDY DENTAL DAM - Natural Rubber Latex - 6" x 6" - Thin - Blue | 
| 00686864060338 | HEDY DENTAL DAM - Natural Rubber Latex - 6" x 6" - Medium - Blue | 
| 00686864060321 | HEDY DENTAL DAM - Natural Rubber Latex - 6"x6" - Heavy - Blue | 
| 00686864060314 | HEDY DENTAL DAM - Natural Rubber Latex - 5"x5" - Thin - Blue | 
| 00686864060307 | HEDY DENTAL DAM - Natural Rubber Latex - 5"x5" - Medium - Blue | 
| 00686864060291 | HEDY DENTAL DAM - Natural Rubber Latex - 5"x5" - Heavy - Blue |