BioBrace 23mm BB23X30

GUDID 00860006566715

Biorez, Inc.

Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Primary Device ID00860006566715
NIH Device Record Key6b14d3ce-1c86-43fc-8df7-5b6bf71690e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioBrace 23mm
Version Model NumberBB23X30
Catalog NumberBB23X30
Company DUNS081048222
Company NameBiorez, Inc.
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

Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com
Phone833-324-6739
Emailinfo@biorez.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100860006566715 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-01
Device Publish Date2021-05-24

Devices Manufactured by Biorez, Inc.

00860006566708 - BioBrace 5mm2021-06-01
00860006566715 - BioBrace 23mm2021-06-01
00860006566715 - BioBrace 23mm2021-06-01
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