Restella

GUDID 09421904065956

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 Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite
Primary Device ID09421904065956
NIH Device Record Key058ba07a-9c41-43ea-9399-c357260284d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameRestella
Version Model NumberR20143-0820P
Company DUNS594540572
Company NameAROA BIOSURGERY LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com
Phone8448352246
Emailcustomerservice@telabio.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109421904065956 [Primary]

FDA Product Code

FTMMesh, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-22
Device Publish Date2019-04-30

On-Brand Devices [Restella ]

09421905067225Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi
09421905067218Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi
09421905067201Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi
09421905067195Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi
09421905067188Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi
09421905067171Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi
09421905067164Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi
09421905067133Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi
09421905067126Restella™is for implantation to reinforce soft tissue where weakness exists in patients requir
09421905067119Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi
09421905067065Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi
09421905067058Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi
09421905067041Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi
09421905067034Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi
09421905067027Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi
09421905067010Restella™is for implantation to reinforce soft tissue where weakness exists in patients requir
09421905067003Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi
09421904065994Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi
09421904065987Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi
09421904065970Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi
09421904065963Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi
09421904065956Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi
09421904065949Restella™ is for implantation to reinforce soft tissue where weakness exists in patients requi
09421904065932Restella™ 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
RESTELLA
87666610 5829515 Live/Registered
TELA Bio, Inc.
2017-10-31

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