BioBrace® RC Delivery System BBRC-35

GUDID 30653405990219

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

Conmed Corporation

Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

• Primary Device ID: 30653405990219
• NIH Device Record Key: aa1082ff-587e-45be-8ae0-4dc16253ff63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioBrace® RC Delivery System
• Version Model Number: BBRC-35
• Catalog Number: BBRC-35
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com
• Phone: +1(866)426-6633
• Email: CustomerExperience@conmed.com

Device Dimensions

• Width: 35 Millimeter
• Length: 25 Millimeter
• Width: 35 Millimeter
• Length: 25 Millimeter
• Width: 35 Millimeter
• Length: 25 Millimeter
• Width: 35 Millimeter
• Length: 25 Millimeter
• Width: 35 Millimeter
• Length: 25 Millimeter
• Width: 35 Millimeter
• Length: 25 Millimeter
• Width: 35 Millimeter
• Length: 25 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY

Device Identifiers

Device Issuing Agency	Device ID
GS1	20653405990212 [Primary]
GS1	30653405990219 [Package]; Contains: 20653405990212; Package: Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250395

FDA Product Code

• OWW: Mesh, surgical, absorbable, orthopaedics, reinforcement of tendon

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[30653405990219]

Ethylene Oxide

[30653405990219]

Ethylene Oxide

[30653405990219]

Ethylene Oxide

[30653405990219]

Ethylene Oxide

[30653405990219]

Ethylene Oxide

[30653405990219]

Ethylene Oxide

[30653405990219]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-21
• Device Publish Date: 2025-04-11

On-Brand Devices [BioBrace® RC Delivery System]

• 30653405990219: BioBrace® RC Delivery System, 35x25mm Implant with delivery instrument
• 30653405990202: BioBrace® RC Delivery System, 23x25mm Implant with delivery instrument