| Primary Device ID | 10610888002163 |
| NIH Device Record Key | 41ab3d32-c9b7-4b3e-aa43-f0066e1c9a42 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GEMCORE360 |
| Version Model Number | PHMB Silicone Adhesive Foam Border |
| Catalog Number | AM-WC-SPHMBFB33 |
| Company DUNS | 770434090 |
| Company Name | ADVANCED MEDICAL SOLUTIONS LIMITED |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10610888002163 [Primary] |
| FRO | Dressing, Wound, Drug |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-15 |
| Device Publish Date | 2022-12-07 |
| 10610888002170 | Silicone PHMB Foam Border Dressings. |
| 10610888002163 | Silicone PHMB Foam Border Dressing. |
| 10610888002156 | 41-24AP Silver HPD |
| 10610888002149 | 41-24AP Silver HPD |
| 10610888002132 | 41-24AP Silver HPD |
| 10610888002064 | Hydrogel Tube 15g |
| 10610888002057 | Hydrogel Tube 8g |
| 10610888000398 | Hydrocolloid Foam Backed Dressing. |
| 10610888000381 | Hydrocolloid Foam Backed Dressings |
| 10610888000374 | Hydrocolloid Foam Backed Dressing. |
| 10610888000367 | Hydrocolloid Film Backed Dressings. |
| 10610888000350 | Hydrocolloid Film Backed Dressings |
| 10610888000343 | Hydrocolloid Film Backed Dressing. |
| 10610888000336 | PHMB Foam Non-Adhesive (Gamma) |
| 10610888000329 | PHMB Foam Non-Adhesive (Gamma) |
| 10610888000312 | PHMB Foam Adhesive |
| 10610888000305 | PHMB Foam Adhesive |
| 10610888000299 | Foam Lite Non Border |
| 10610888000282 | Foam Lite Non Border |
| 10610888000275 | Foam Lite Border |
| 10610888000268 | Foam Lite Border |
| 10610888000251 | Silicone Trilaminate Foam Non-Border |
| 10610888000244 | Silicone Trilaminate Foam Non-Border |
| 10610888000237 | Silicone Trilaminate Foam Non-Border |
| 10610888000220 | Silicone Trilaminate Foam Border |
| 10610888000213 | Silicone Trilaminate Foam Border |
| 10610888000206 | Silicone Trilaminate Foam Border |
| 10610888000190 | 41-21AP |
| 10610888000183 | 41-21AP |
| 10610888000176 | 41-21AP |
| 10610888000169 | 14-24DP Silver Alginate IV |
| 10610888000152 | 14-24DP Silver Alginate IV |
| 10610888000145 | 14-24DP Silver Alginate IV |
| 10610888000138 | 1-21DP Reinforced |
| 10610888000121 | 1-21DP Reinforced |
| 10610888000114 | 1-21DP Reinforced |
| 10610888002071 | Silver Gel Tube 45g, flowerpot |