| Primary Device ID | 09421904065598 |
| NIH Device Record Key | d7e21953-67c1-41b9-8293-15a7b4344dae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Endoform Antimicrobial Dermal Template |
| Version Model Number | 629313 |
| Catalog Number | 629313 |
| Company DUNS | 594540572 |
| Company Name | AROA BIOSURGERY 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 877-627-6224 |
| customerservice@aroabio.com |
| Width | 10 Centimeter |
| Special Storage Condition, Specify | Between 0 and 0 *clean and dry area, away from direct light |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09421904065437 [Primary] |
| GS1 | 09421904065512 [Package] Contains: 09421904065437 Package: CARTON [10 Units] In Commercial Distribution |
| GS1 | 09421904065598 [Package] Contains: 09421904065512 Package: SHIPPER [50 Units] In Commercial Distribution |
| FRO | Dressing, Wound, Drug |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-05-06 |
| Device Publish Date | 2018-03-31 |
| 09421905067348 | Endoform Antimicrobial Dermal Template is a sterile, single use ovine forestomach-derived extrac |
| 09421905067379 | Endoform Antimicrobial Dermal Template is a sterile, single use ovine forestomach-derived extrac |
| 09421905067386 | Endoform Antimicrobial Dermal Template is a sterile, single use ovine forestomach-derived extrac |
| 09421904065611 | Endoform Antimicrobial Dermal Template is a sterile, single use ovine forestomach-derived extrac |
| 09421904065604 | Endoform Antimicrobial Dermal Template is a sterile, single use ovine forestomach-derived extrac |
| 09421904065598 | Endoform Antimicrobial Dermal Template is a sterile, single use ovine forestomach-derived extrac |
| 09421904065420 | Endoform Antimicrobial Dermal Template is a sterile, single use ovine forestomach-derived extrac |