BioBrace® RC Delivery System

Basic Information

• Brand Name: BioBrace® RC Delivery System
• Primary DI: 20653405990212
• Version / Model: BBRC-35
• Catalog Number: BBRC-35
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-11
• Public Version: 1
• Public Version Date: 2025-04-21
• Public Version Status: New
• Public Device Record Key: aa1082ff-587e-45be-8ae0-4dc16253ff63

Device Description

BioBrace® RC Delivery System, 35x25mm Implant with delivery instrument

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OWW	Mesh, surgical, absorbable, orthopaedics, reinforcement of tendon	General, Plastic Surgery	878.3300	2
ORQ	Mesh, surgical, deployer	General, Plastic Surgery	878.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60907	Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial	A 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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30653405990219	GS1	Carton	1	In Commercial Distribution
Primary	20653405990212	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K250395	000

Device Sizes

Type	Value	Unit	Text
Width	35	Millimeter
Length	25	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 32 – 104 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: KEEP DRY