Ovitex® PRS

GUDID 09421905067874

Ovitex® PRS 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 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 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 ID09421905067874
NIH Device Record Keyb42a6ca1-60c7-42f3-9dae-dff945a963d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameOvitex® PRS
Version Model NumberR30343-2022P
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
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
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
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
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109421905067874 [Primary]

FDA Product Code

FTLMesh, Surgical, Polymeric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-11
Device Publish Date2019-11-01

On-Brand Devices [Ovitex® PRS]

09421905067904Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067898Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067881Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067874Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067867Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067850Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067843Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067836Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067829Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067812Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067805Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067799Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067782Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067775Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067768Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067751Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067744Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067737Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067720Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067713Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067706Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067690Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067683Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067676Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067669Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067652Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067645Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067638Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067157Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421905067140Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421906017052Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ
09421906017045Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ

Trademark Results [Ovitex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OVITEX
OVITEX
86761323 5065654 Live/Registered
TELA Bio, Inc.
2015-09-18

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