BioBrace

Basic Information

• Brand Name: BioBrace
• Primary DI: 10653405988960
• Version / Model: BB23X30-FA
• Catalog Number: BB23X30-FA
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-12
• Public Version: 1
• Public Version Date: 2024-02-20
• Public Version Status: New
• Public Device Record Key: 4f97477b-f96b-4f19-bb04-7c701551796f

Device Description

BioBrace Reinforce BioInductive Implant, 23 x 30 mm

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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OWW	Mesh, surgical, absorbable, orthopaedics, reinforcement of tendon	General, Plastic Surgery	878.3300	2
OWY	Mesh, surgical, collagen, orthopaedics, reinforcement of tendon	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
Primary	10653405988960	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K203267	000

Device Sizes

Type	Value	Unit	Text
Width	23	Millimeter
Length	30	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 104 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: High: 40 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Do not reuse; Do not resterilize; Do not use if package damaged