Primary Device ID | 00819034023592 |
NIH Device Record Key | 96d32aa6-41cd-448f-bab7-3ef372ca838f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DynaBridge |
Version Model Number | CD-DB-2021 |
Catalog Number | CD-DB-2021 |
Company DUNS | 080307067 |
Company Name | FUSION ORTHOPEDICS, LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00819034023592 [Primary] |
JDR | Staple, Fixation, Bone |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00819034023592]
Moist Heat or Steam Sterilization
[00819034023592]
Moist Heat or Steam Sterilization
[00819034023592]
Moist Heat or Steam Sterilization
[00819034023592]
Moist Heat or Steam Sterilization
[00819034023592]
Moist Heat or Steam Sterilization
[00819034023592]
Moist Heat or Steam Sterilization
[00819034023592]
Moist Heat or Steam Sterilization
[00819034023592]
Moist Heat or Steam Sterilization
[00819034023592]
Moist Heat or Steam Sterilization
[00819034023592]
Moist Heat or Steam Sterilization
[00819034023592]
Moist Heat or Steam Sterilization
[00819034023592]
Moist Heat or Steam Sterilization
[00819034023592]
Moist Heat or Steam Sterilization
[00819034023592]
Moist Heat or Steam Sterilization
[00819034023592]
Moist Heat or Steam Sterilization
[00819034023592]
Moist Heat or Steam Sterilization
[00819034023592]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-05-07 |
Device Publish Date | 2019-04-29 |
00819034029273 | Sizer Wheel Kit |
00819034028016 | Superelastic Nitinol Implant Style B 25mm x 20mm x 20mm |
00819034028009 | Superelastic Nitinol Implant Style B 20mm x 20mm x 20mm |
00819034027996 | Superelastic Nitinol Implant Style B 20mm x 15mm x 15mm |
00819034027989 | Superelastic Nitinol Implant Style B 18mm x 18mm x 15mm |
00819034027972 | Superelastic Nitinol Implant Style B 18mm x 18mm x 18mm |
00819034027965 | Superelastic Nitinol Implant Style B 18mm x 15mm x 15mm |
00819034027958 | Superelastic Nitinol Implant Style B 15mm x 15mm x 15mm |
00819034027941 | Superelastic Nitinol Implant Style B 15mm x 12mm x 12mm |
00819034027934 | Superelastic Nitinol Implant Style A 15mm x 12mm x 12mm |
00819034027910 | Superelastic Nitinol Implant Style A 13mm x 10mm x 10mm |
00819034027897 | Superelastic Nitinol Implant Style A 11mm x 10mm x 10mm |
00819034027880 | Superelastic Nitinol Implant Style A 9 x 8 x 8mm (Single) |
00819034027873 | Drill Guide Style B 25mm |
00819034027866 | Drill Guide Style B 20mm |
00819034027859 | Drill Guide Style B 18mm |
00819034027842 | Drill Guide Style B 15mm |
00819034027835 | Drill Guide Style A 15mm |
00819034027828 | Drill Guide Style A 13mm |
00819034027811 | Drill Guide Style A 11mm |
00819034027804 | Sizer Wheel Style B |
00819034027798 | Drill Guide Style A 9mm |
00819034027781 | Sizer Wheel Style A |
00819034027774 | Sizer Wheel Style B |
00819034027255 | Sizer Wheel Style A |
00819034025398 | Tamp Large |
00819034025381 | Tamp Small |
00819034025213 | Superelastic Nitinol Implant System Style B 15 x 12 x 12mm |
00819034025206 | Superelastic Nitinol Implant Style B 15 x 12 x 12mm |
00819034023776 | Tray Based Inserter 25mm |
00819034023769 | Tray Based Inserter 20mm |
00819034023752 | Tray Based Inserter 18mm |
00819034023745 | Tray Based Inserter 15mm |
00819034023738 | Tray Based Inserter 13mm |
00819034023721 | Tray Based Inserter 11mm |
00819034023714 | Tray Based Inserter 9mm |
00819034023653 | Calibrated Drill 15mm Length 2.1mm |
00819034023639 | Targeting Rod Large |
00819034023622 | Targeting Rod Small |
00819034023615 | Calibrated Drill 2.8mm |
00819034023608 | Calibrated Drill 15mm Length 2.1mm |
00819034023592 | Calibrated Drill 2.1mm |
00819034023585 | Superelastic Nitinol Implant System Style B 25 x 20 x 20m |
00819034023578 | Superelastic Nitinol Implant System Style B 20 x 20 x 20mm |
00819034023561 | Superelastic Nitinol Implant System Style B 20 x 15 x 15mm |
00819034023554 | Superelastic Nitinol Implant System Style B 18 x 18 x 15mm |
00819034023547 | Superelastic Nitinol Implant System Style B 18 x 18 x 18mm |
00819034023530 | Superelastic Nitinol Implant System Style B 18 x 15 x 15mm |
00819034023523 | Superelastic Nitinol Implant System Style B 15 x 15 x 15mm |
00819034023516 | Superelastic Nitinol Implant System Style A 15 x 12 x 12mm |