FDA.reportPublic FDA data

BioBrace® RC Delivery System

Primary DI
20653405990205
Brand
BioBrace® RC Delivery System
Company
Conmed Corporation
Model
BBRC-23
Catalog number
BBRC-23
Device description
BioBrace® RC Delivery System, 23x25mm Implant with delivery instrument
Published
2025-04-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ORQMesh, surgical, deployer
OWWMesh, surgical, absorbable, orthopaedics, reinforcement of tendon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ORQMesh, Surgical, DeployerGeneral, Plastic Surgery2
OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250395000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250395000BioBrace ® RC Delivery SystemConmed Corporation2025-04-07ORQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30653405990202PackageGS11In Commercial Distribution
20653405990205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3065340599020230653405990202
2065340599020520653405990205

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobialA bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25Millimeter
Width23Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP DRY
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature32 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

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Primary DIBrandModelCatalogPublished
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10845854031841CONMEDT2531T25312020-12-10
10845854036204POWERPROPRO6185PRO61852023-09-01
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30653405988346Argo KnotlessK55RTAPK55RTAP2023-01-13
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10845854032619CROSSFTTFT-45MTFT-45M2021-01-19
10845854032633CROSSFTTFT-55MTFT-55M2021-01-19
10845854032657CROSSFTTFT-65MTFT-65M2021-01-19
10653405004646ELECTROLASE HYFRECATOR7-100-8BX7-100-8BX2016-09-24
10653405013785THERMOGARD7-3847-3842016-09-24
10845854650134THERMOGARD7-3827-3822022-09-21
20653405051906Precisor0008520008522016-09-24
20653405051920Precisor0008540008542016-09-24
30653405046800BiCap SuperconductorBP-10300ABP-10300A2016-09-24
30653405046992BiCap SuperconductorBP-7300ABP-7300A2016-09-24
30653405047005BiCap SuperconductorBP-5200ABP-5200A2016-09-24

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Primary DI, Brand, Company table
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