BioBrace BB23X30
GUDID 10653405988953
BioBrace Reinforce BioInductive Implant, 23 x 30 mm
Conmed Corporation
Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial| Primary Device ID | 10653405988953 |
| NIH Device Record Key | 806ece3a-0f02-4798-9a16-d3b9d11b4590 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioBrace |
| Version Model Number | BB23X30 |
| Catalog Number | BB23X30 |
| 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 | false |
| 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 | 23 Millimeter |
| Length | 30 Millimeter |
| Width | 23 Millimeter |
| Length | 30 Millimeter |
| Width | 23 Millimeter |
| Length | 30 Millimeter |
| Width | 23 Millimeter |
| Length | 30 Millimeter |
| Width | 23 Millimeter |
| Length | 30 Millimeter |
| Width | 23 Millimeter |
| Length | 30 Millimeter |
| Width | 23 Millimeter |
| Length | 30 Millimeter |
| Width | 23 Millimeter |
| Length | 30 Millimeter |
| Width | 23 Millimeter |
| Length | 30 Millimeter |
| Width | 23 Millimeter |
| Length | 30 Millimeter |
| Width | 23 Millimeter |
| Length | 30 Millimeter |
| Width | 23 Millimeter |
| Length | 30 Millimeter |
| Width | 23 Millimeter |
| Length | 30 Millimeter |
| Width | 23 Millimeter |
| Length | 30 Millimeter |
| Width | 23 Millimeter |
| Length | 30 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not reuse; Do not resterilize; Do not use if package damaged |
| Storage Environment Temperature | Between 0 and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860006566715 [Previous] |
| GS1 | 10653405988953 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K203267
FDA Product Code
| OWW | Mesh, surgical, absorbable, orthopaedics, reinforcement of tendon |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-20 |
| Device Publish Date | 2024-02-12 |
On-Brand Devices [BioBrace]
| 10653405988960 | BioBrace Reinforce BioInductive Implant, 23 x 30 mm |
| 10653405988953 | BioBrace Reinforce BioInductive Implant, 23 x 30 mm |
| 10653405988939 | BioBrace Reinforce BioInductive Implant, 5 x 250 mm |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.