Endoform™ Natural Restorative Bioscaffold 529313
GUDID 09421906017373
Endoform™ Natural Restorative Bioscaffold is a sterile, single use ovine forestomach-derived extracellular matrix intended to cover, protect, and provide a moist wound environment.
AROA BIOSURGERY LIMITED
Collagen wound matrix dressing| Primary Device ID | 09421906017373 |
| NIH Device Record Key | 6ea1a4cd-578d-4ff2-bbbb-63720f2bb7b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Endoform™ Natural Restorative Bioscaffold |
| Version Model Number | 529313 |
| Catalog Number | 529313 |
| 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 | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
Customer Support Contacts
| Phone | 877-627-6224 |
| customerservice@aroabio.com | |
| Phone | 877-627-6224 |
| customerservice@aroabio.com | |
| Phone | 877-627-6224 |
| customerservice@aroabio.com | |
| Phone | 877-627-6224 |
| customerservice@aroabio.com | |
| Phone | 877-627-6224 |
| customerservice@aroabio.com | |
| Phone | 877-627-6224 |
| customerservice@aroabio.com | |
| Phone | 877-627-6224 |
| customerservice@aroabio.com | |
| Phone | 877-627-6224 |
| customerservice@aroabio.com | |
| Phone | 877-627-6224 |
| customerservice@aroabio.com |
Device Dimensions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09421906017267 [Primary] |
| GS1 | 09421906017373 [Package] Contains: 09421906017267 Package: Carton [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092096
FDA Product Code
| KGN | Dressing, Wound, Collagen |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-30 |
| Device Publish Date | 2021-08-20 |
On-Brand Devices [Endoform™ Natural Restorative Bioscaffold]
| 09421906017410 | Endoform™ Natural Restorative Bioscaffold is a sterile, single use ovine forestomach-derived e |
| 09421906017298 | Endoform™ Natural Restorative Bioscaffold is a sterile, single use ovine forestomach-derived e |
| 09421906017397 | Endoform™ Natural Restorative Bioscaffold is a sterile, single use ovine forestomach-derived e |
| 09421906017380 | Endoform™ Natural Restorative Bioscaffold is a sterile, single use ovine forestomach-derived e |
| 09421906017373 | Endoform™ Natural Restorative Bioscaffold is a sterile, single use ovine forestomach-derived e |
| 09421906017366 | Endoform™ Natural Restorative Bioscaffold is a sterile, single use ovine forestomach-derived e |
| 09421906017359 | Endoform™ Natural Restorative Bioscaffold is a sterile, single use ovine forestomach-derived e |
| 09421906017342 | Endoform™ Natural Restorative Bioscaffold is a sterile, single use ovine forestomach-derived e |
Trademark Results [Endoform]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOFORM 85366013 4224124 Live/Registered |
AROA BIOSURGERY LIMITED 2011-07-07 |
 ENDOFORM 79325081 not registered Live/Pending |
AROA BIOSURGERY LIMITED 2021-07-14 |
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