BioBrace 5mm BB5X250

GUDID 00860006566708

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 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 ID00860006566708
NIH Device Record Keyf2d659ba-db4f-4511-ae82-52702a77ff33
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioBrace 5mm
Version Model NumberBB5X250
Catalog NumberBB5X250
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
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com

Device Dimensions

Length250 Millimeter
Width5 Millimeter
Length250 Millimeter
Width5 Millimeter
Length250 Millimeter
Width5 Millimeter
Length250 Millimeter
Width5 Millimeter
Length250 Millimeter
Width5 Millimeter
Length250 Millimeter
Width5 Millimeter
Length250 Millimeter
Width5 Millimeter
Length250 Millimeter
Width5 Millimeter
Length250 Millimeter
Width5 Millimeter
Length250 Millimeter
Width5 Millimeter
Length250 Millimeter
Width5 Millimeter
Length250 Millimeter
Width5 Millimeter
Length250 Millimeter
Width5 Millimeter
Length250 Millimeter
Width5 Millimeter
Length250 Millimeter
Width5 Millimeter

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
Special Storage Condition, SpecifyBetween 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged
Storage Environment TemperatureBetween 0 and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100860006566708 [Primary]
GS110653405988946 [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
00860006566708 - BioBrace 5mm2021-06-01
00860006566715 - BioBrace 23mm2021-06-01
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