Restella
GUDID 09421904065970
Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
AROA BIOSURGERY LIMITED
Multi-purpose surgical mesh, biologic-polymer composite| Primary Device ID | 09421904065970 |
| NIH Device Record Key | 45318876-8406-479c-9bd9-29e5c538fa51 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Restella |
| Version Model Number | R20243-0815P |
| Company DUNS | 594540572 |
| Company Name | AROA BIOSURGERY LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 8448352246 |
| customerservice@telabio.com | |
| Phone | 8448352246 |
| customerservice@telabio.com | |
| Phone | 8448352246 |
| customerservice@telabio.com | |
| Phone | 8448352246 |
| customerservice@telabio.com | |
| Phone | 8448352246 |
| customerservice@telabio.com | |
| Phone | 8448352246 |
| customerservice@telabio.com | |
| Phone | 8448352246 |
| customerservice@telabio.com | |
| Phone | 8448352246 |
| customerservice@telabio.com | |
| Phone | 8448352246 |
| customerservice@telabio.com | |
| Phone | 8448352246 |
| customerservice@telabio.com | |
| Phone | 8448352246 |
| customerservice@telabio.com | |
| Phone | 8448352246 |
| customerservice@telabio.com | |
| Phone | 8448352246 |
| customerservice@telabio.com | |
| Phone | 8448352246 |
| customerservice@telabio.com | |
| Phone | 8448352246 |
| customerservice@telabio.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09421904065970 [Primary] |
FDA Product Code
| FTM | Mesh, Surgical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-10-22 |
| Device Publish Date | 2019-04-30 |
On-Brand Devices [Restella ]
| 09421905067225 | Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi |
| 09421905067218 | Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi |
| 09421905067201 | Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi |
| 09421905067195 | Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi |
| 09421905067188 | Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi |
| 09421905067171 | Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi |
| 09421905067164 | Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi |
| 09421905067133 | Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi |
| 09421905067126 | Restella™is for implantation to reinforce soft tissue where weakness exists in patients requir |
| 09421905067119 | Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi |
| 09421905067065 | Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi |
| 09421905067058 | Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi |
| 09421905067041 | Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi |
| 09421905067034 | Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi |
| 09421905067027 | Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi |
| 09421905067010 | Restella™is for implantation to reinforce soft tissue where weakness exists in patients requir |
| 09421905067003 | Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi |
| 09421904065994 | Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi |
| 09421904065987 | Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi |
| 09421904065970 | Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi |
| 09421904065963 | Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi |
| 09421904065956 | Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi |
| 09421904065949 | Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi |
| 09421904065932 | Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi |
Trademark Results [Restella]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RESTELLA 87666610 5829515 Live/Registered |
TELA Bio, Inc. 2017-10-31 |
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