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 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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
[30653405990219]
Ethylene Oxide
[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 |
Trademark Results [BioBrace]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOBRACE 88322262 not registered Live/Pending |
Biorez, Inc. 2019-03-01 |
 BIOBRACE 87245826 5232413 Live/Registered |
Raven Computer Inc. 2016-11-22 |
 BIOBRACE 78423516 not registered Dead/Abandoned |
MEDI BAYREUTH GMBH & CO. KG 2004-05-23 |
 BIOBRACE 77349610 3772206 Dead/Cancelled |
BioBrace LLC 2007-12-11 |
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