Juveno™ Femoral Hip System 8819077000
GUDID 00843575106827
Straight Broach Handle, Trigger Style
B-ONE ORTHO, CORP.
Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting| Primary Device ID | 00843575106827 |
| NIH Device Record Key | bd9bd483-47df-46b7-b1b7-30eae9888353 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Juveno™ Femoral Hip System |
| Version Model Number | 8819077000 |
| Catalog Number | 8819077000 |
| Company DUNS | 081315444 |
| Company Name | B-ONE ORTHO, CORP. |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843575106827 [Primary] |
FDA Product Code
| LXH | Orthopedic Manual Surgical Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00843575106827]
Moist Heat or Steam Sterilization
[00843575106827]
Moist Heat or Steam Sterilization
[00843575106827]
Moist Heat or Steam Sterilization
[00843575106827]
Moist Heat or Steam Sterilization
[00843575106827]
Moist Heat or Steam Sterilization
[00843575106827]
Moist Heat or Steam Sterilization
[00843575106827]
Moist Heat or Steam Sterilization
[00843575106827]
Moist Heat or Steam Sterilization
[00843575106827]
Moist Heat or Steam Sterilization
[00843575106827]
Moist Heat or Steam Sterilization
[00843575106827]
Moist Heat or Steam Sterilization
[00843575106827]
Moist Heat or Steam Sterilization
[00843575106827]
Moist Heat or Steam Sterilization
[00843575106827]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-13 |
| Device Publish Date | 2020-07-03 |
On-Brand Devices [Juveno™ Femoral Hip System]
| 00843575106001 | Femoral Broach Tray |
| 00843575105998 | Femoral General Tray |
| 00843575104113 | Sterilization Case |
| 00843575103932 | Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 11, Standa |
| 00843575103925 | Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 10, Standa |
| 00843575103918 | Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 9, Standar |
| 00843575103901 | Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 8, Standar |
| 00843575103895 | Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 7, Standar |
| 00843575103888 | Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 6, Standar |
| 00843575103871 | Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 5, Standar |
| 00843575103864 | Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 4, Standar |
| 00843575103857 | Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 3, Standar |
| 00843575103840 | Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 2, Standar |
| 00843575103833 | Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 1, Standar |
| 00843575103826 | Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 11, High ( |
| 00843575103819 | Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 10, High ( |
| 00843575103802 | Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 9, High (1 |
| 00843575103796 | Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 8, High (1 |
| 00843575103789 | Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 7, High (1 |
| 00843575103772 | Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 6, High (1 |
| 00843575103765 | Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 5, High (1 |
| 00843575103758 | Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 4, High (1 |
| 00843575103741 | Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 3, High (1 |
| 00843575103734 | Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 2, High (1 |
| 00843575103727 | Cementless Femoral Stem, b-ONE™ 12/14 Taper; Porous Plasma Spray + HA coating; Size 1, High (1 |
| 00843575102850 | STRAIGHT BROACH HANDLE |
| 00843575102843 | T-HANDLE |
| 00843575102836 | NECK TRIAL, STANDARD OFFSET (132°), 40MM LENGTH |
| 00843575102829 | NECK TRIAL, STANDARD OFFSET (132°), 37MM LENGTH |
| 00843575102812 | NECK TRIAL, STANDARD OFFSET (132°), 35MM LENGTH |
| 00843575102805 | NECK TRIAL, STANDARD OFFSET (132°), 30MM LENGTH |
| 00843575102799 | NECK TRIAL, STANDARD OFFSET (132°), 27MM LENGTH |
| 00843575102782 | NECK TRIAL, HIGH OFFSET (127°), 40MM LENGTH |
| 00843575102775 | NECK TRIAL, HIGH OFFSET (127°), 37MM LENGTH |
| 00843575102768 | NECK TRIAL, HIGH OFFSET (127°), 35MM LENGTH |
| 00843575102751 | NECK TRIAL, HIGH OFFSET (127°), 30MM LENGTH |
| 00843575102744 | NECK TRIAL, HIGH OFFSET (127°), 27MM LENGTH |
| 00843575102737 | CORKSCREW |
| 00843575102720 | MODULAR HEAD IMPACTOR |
| 00843575102713 | AXIAL HANDLE |
| 00843575102706 | MODULAR BOX CHISEL |
| 00843575102690 | MALLET |
| 00843575102683 | CALCAR PLANER 32MM |
| 00843575102676 | STARTER REAMER |
| 00843575102669 | STEM IMPACTOR |
| 00843575102652 | STEM INSERTER, OFFSET |
| 00843575102645 | STEM REMOVER |
| 00843575102638 | FEMORAL RESECTION GUIDE |
| 00843575100122 | BROACH, SIZE 11 |
| 00843575100115 | BROACH, SIZE 10 |
Trademark Results [Juveno]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 JUVENO 87900263 5829762 Live/Registered |
B-ONE MEDICAL BIOTECH CORPORATION 2018-04-30 |
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