FDA.reportPublic FDA data

BioBrace 5mm

Primary DI
00860006566708
Brand
BioBrace 5mm
Company
Biorez, Inc.
Model
BB5X250
Catalog number
BB5X250
Published
2021-05-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWTMesh, surgical, absorbable, abdominal hernia
OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWTMesh, Surgical, Absorbable, Abdominal HerniaGeneral, Plastic Surgery2
OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2
OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203267000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203267000The BioBrace ImplantBiorez, Inc.2021-04-30OWW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20653405988943PackageGS11In Commercial Distribution
00860006566708PrimaryGS10
10653405988946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2065340598894320653405988943
00860006566708008600065667088600065667080860006566708
1065340598894610653405988946

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, collagen, bioabsorbableA sterile, bioabsorbable, flat or three-dimensional (3-D) implantable material made from animal-derived collagen intended for multiple tissue defect repair/hernia reduction (e.g., inguinal, ventral/incisional, umbilical, femoral) applications including an extra-abdominal application(s) [e.g., plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Millimeter
Length250Millimeter
Width5Millimeter
Width250Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Do not reuse; Do not resterilize; Do not use if package damaged
Storage Environment Temperature040 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature0104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
833 324 6739info@biorez.com
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
081048222
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860006566715BioBrace 23mmBB23X30BB23X302021-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812337020695Medeor Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
00812337020701Medeor Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
00812337020794Meso Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
00812337020800Meso Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
00812337020817Meso Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
00812337020824Meso Tendon MatrixDSM BIOMEDICAL, INC.OWY2026-03-24
05694310966443Kerecis SurgiBind® Tendon ProtectKERECIS hf.OWY2026-02-03
05694310966474Kerecis SurgiBind® Tendon ProtectKERECIS hf.OWY2026-02-03
05694310966467Kerecis SurgiBind® Tendon ProtectKERECIS hf.OWY2026-02-03
05694310966450Kerecis SurgiBind® Tendon ProtectKERECIS hf.OWY2026-02-03
B454VTP12G10VersaCoat Flowable HydrogelAlafair Biosciences, Inc.OWW2025-12-21
00860011716730B3 GEL SystemTybr Health, Inc.OWY2025-12-17
00888867395084Arthrex®ARTHREX, INC.OWY2025-12-01
00888867395091Arthrex®ARTHREX, INC.OWY2025-12-01
00888867543133Arthrex®ARTHREX, INC.OWY2025-12-01
00888867543140Arthrex®ARTHREX, INC.OWY2025-12-01
B454VTP44G20VersaCoat Flowable HydrogelAlafair Biosciences, Inc.OWW2025-11-21
20653405990700BioBraceConmed CorporationOWW2025-10-28
30653405990707BioBraceConmed CorporationOWW2025-10-28
07332999000222TIGR® Matrix Surgical MeshNovus Scientific ABOWT2025-08-29
07332999000239TIGR® Matrix Surgical MeshNovus Scientific ABOWT2025-08-29
07332999000246TIGR® Matrix Surgical MeshNovus Scientific ABOWT2025-08-29
07332999000468TIGR® Matrix Surgical MeshNovus Scientific ABOWT2025-08-29
07332999000475TIGR® Matrix Surgical MeshNovus Scientific ABOWT2025-08-29
06975222391004SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391011SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391028SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391035SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391042SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20
06975222391059SpinMedix® Absorbable Fibrous MembraneNingbo Guangyuan Zhixin Biological Technology Co., Ltd.OWW2025-05-20