FDA.reportPublic FDA data

BioBrace® RC Delivery System

Primary DI
30653405990202
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
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ORQMesh, surgical, deployer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ORQMesh, Surgical, DeployerGeneral, 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10845854051399AirSealiAS8-dViAS8-dV2021-08-22
10845854084137AirSeal®iAS8-dVLiAS8-dVL2023-01-06
10845854013137QUICKLATCHQL4300QL43002020-12-10
10845854031841CONMEDT2531T25312020-12-10
10845854036204POWERPROPRO6185PRO61852023-09-01
20845854061807SnapEvacSNAPEVAC20SNAPEVAC202020-06-06
30653405011907EXCEL60-6050-00160-6050-0012016-09-24
30653405988346Argo KnotlessK55RTAPK55RTAP2023-01-13
30653405988360Argo KnotlessK475RTAPK475RTAP2023-01-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20653405990205BioBrace® RC Delivery SystemConmed CorporationORQ2025-04-11
20653405990212BioBrace® RC Delivery SystemConmed CorporationORQ2025-04-11
00885556735657Bioinductive Implant with Arthroscopic Delivery System - MediumSmith & Nephew, Inc.ORQ2019-08-20
00885556735664Bioinductive Implant with Arthroscopic Delivery System - LargeSmith & Nephew, Inc.ORQ2019-08-20
00801741161247PhasixDavol Inc.ORQ2019-08-16
00801741161292PhasixDavol Inc.ORQ2019-08-16
00801741161216PhasixDavol Inc.ORQ2019-07-12
00801741161223PhasixDavol Inc.ORQ2019-07-12
00801741161230PhasixDavol Inc.ORQ2019-07-12
00801741161254PhasixDavol Inc.ORQ2019-07-12
00801741161261PhasixDavol Inc.ORQ2019-07-12
00801741161278PhasixDavol Inc.ORQ2019-07-12
00801741161285PhasixDavol Inc.ORQ2019-07-12
00801741161308PhasixDavol Inc.ORQ2019-07-12
00854501006128Bioinductive Implant with Arthroscopic Delivery System - HybridSmith & Nephew, Inc.ORQ2018-01-09
00854501006135Bioinductive Implant with Arthroscopic Delivery System - LargeSmith & Nephew, Inc.ORQ2018-01-09
00854501006142Bioinductive Implant with Arthroscopic Delivery System - MediumSmith & Nephew, Inc.ORQ2018-01-09
00854501006098Rotation Medical Reconstituted Collagen Scaffold - Arthroscopic, HybridSmith & Nephew, Inc.ORQ2017-11-28
00801741130977VENTRALIGHTDavol Inc.ORQ2017-08-25
00801741130984VENTRALIGHTDavol Inc.ORQ2017-08-25
00801741130991VENTRALIGHTDavol Inc.ORQ2017-08-25
00801741131004VENTRALIGHTDavol Inc.ORQ2017-08-25
00801741131011VENTRALIGHTDavol Inc.ORQ2017-08-25
00801741131028VENTRALIGHTDavol Inc.ORQ2017-08-25
00801741131035VENTRALIGHTDavol Inc.ORQ2017-08-25
00801741131042VENTRALIGHTDavol Inc.ORQ2017-08-25
00801741131059VENTRALIGHTDavol Inc.ORQ2017-08-25
00801741131066VENTRALIGHTDavol Inc.ORQ2017-08-25
10884521171282AccuMeshCovidien LPORQ2016-09-24
20884521171289AccuMeshCovidien LPORQ2016-09-24