| Primary Device ID | 20686864061223 |
| NIH Device Record Key | 08bc1d5b-1031-4824-9583-8d0dd78ffeae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MEDICOM SAFEWEAR |
| Version Model Number | 8118-E |
| Catalog Number | 8118-E |
| Company DUNS | 256880576 |
| Company Name | AMD Medicom Inc |
| Device Count | 12 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| 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 |
| 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 | 00686864061229 [Unit of Use] |
| GS1 | 10686864061226 [Primary] |
| GS1 | 20686864061223 [Package] Contains: 10686864061226 Package: Outer case [5 Units] In Commercial Distribution |
| OEA | Non-surgical isolation gown |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-14 |
| Device Publish Date | 2025-02-06 |
| 20686864055062 | MEDICOM SAFEWEAR HIPSTER JACKET |
| 20686864055000 | MEDICOM SAFEWEAR HIPSTER JACKET |
| 20686864054706 | MEDICOM SAFEWEAR HIPSTER JACKET |
| 20686864060684 | MEDICOM SAFEWEAR HIPSTER JACKET Extra Small |
| 20686864061223 | Medicom SafeWear Hipster Jacket - Jet Black - Premium Hip Length Jacket - Jet Black - 2X-Large |