BioBridge
GUDID 10814493010609
18 Hole Resorbable Rib Plate
ACUTE INNOVATIONS LLC
Orthopaedic fixation plate, bioabsorbable| Primary Device ID | 10814493010609 |
| NIH Device Record Key | 1c8fc463-5d72-4d20-9efd-4bf112a68333 |
| Commercial Distribution Discontinuation | 2021-03-03 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | BioBridge |
| Version Model Number | RRP1501 |
| Company DUNS | 619225415 |
| Company Name | ACUTE INNOVATIONS LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 110 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10814493010609 [Primary] |
FDA Product Code
| HRS | Plate, Fixation, Bone |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-04-12 |
| Device Publish Date | 2015-09-03 |
Devices Manufactured by ACUTE INNOVATIONS LLC
| 10814493010012 - RibLoc | 2021-04-12 8mm x 46mm Rib Plate |
| 10814493010029 - RibLoc | 2021-04-12 10mm x 46mm Rib Plate |
| 10814493010036 - RibLoc | 2021-04-12 12mm x 46mm Rib Plate |
| 10814493010043 - RibLoc | 2021-04-12 14mm x 46mm Rib Plate |
| 10814493010050 - RibLoc | 2021-04-12 8mm x 61mm Rib Plate |
| 10814493010067 - RibLoc | 2021-04-12 10mm x 61mm Rib Plate |
| 10814493010074 - RibLoc | 2021-04-12 12mm x 61mm Rib Plate |
| 10814493010081 - RibLoc | 2021-04-12 14mm x 61mm Rib Plate |
Trademark Results [BioBridge]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOBRIDGE 90398421 not registered Live/Pending |
LEAR CORPORATION 2020-12-21 |
 BIOBRIDGE 87592370 not registered Live/Pending |
LEAR CORPORATION 2017-08-31 |
 BIOBRIDGE 79115705 4650810 Live/Registered |
REGEN LAB SA 2012-03-29 |
 BIOBRIDGE 77842834 4139473 Live/Registered |
Fibralign Corporation 2009-10-06 |
 BIOBRIDGE 77816655 3871368 Live/Registered |
Acute Innovations, LLC 2009-08-31 |
 BIOBRIDGE 76049246 2465573 Live/Registered |
Recigno Laboratories Inc. 2000-05-16 |
 BIOBRIDGE 75033374 2010261 Dead/Cancelled |
ENZO BIOCHEM, INC. 1995-12-06 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.