Primary Device ID | 30705036014571 |
NIH Device Record Key | 0bd6a6b1-0a84-4486-b928-cb3cf3432655 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HARMONIC OSTEOVUE |
Version Model Number | HARSB |
Catalog Number | HARSB |
Company DUNS | 107105876 |
Company Name | DEPUY SPINE, LLC |
Device Count | 6 |
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 | 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 |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx |
Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Handling Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -22 Degrees Celsius and 60 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10705036014577 [Unit of Use] |
GS1 | 20705036014574 [Primary] |
GS1 | 30705036014571 [Package] Contains: 20705036014574 Package: CASE [36 Units] In Commercial Distribution |
LFL | Instrument, ultrasonic surgical |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-05-24 |
10705034571102 - N/A | 2025-06-27 ROD HOLDER |
10705034577364 - N/A | 2025-06-27 THREADED REDUCER T-HANDLE, TALL |
10705034577500 - N/A | 2025-06-27 THREADED REDUCER T-HANDLE, SHORT |
10705034577685 - N/A | 2025-06-27 K-WIRE |
10705034577791 - N/A | 2025-06-27 ROD TEMPLATE 5mm x 600mm |
10705034222691 - X-MESH | 2025-06-25 X-MESH EXPANDABLE CAGE SYSTEM TRIAL, LATERAL, SMALL/MEDIUM |
10705034222707 - X-MESH | 2025-06-25 X-MESH EXPANDABLE CAGE SYSTEM TRIAL, LATERAL, MEDIUM/LARGE |
10705034222721 - X-MESH | 2025-06-25 X-MESH EXPANDABLE CAGE SYSTEM TRIAL, ANTERIOR, MEDIUM/LARGE |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() HARMONIC OSTEOVUE 86547804 4942694 Live/Registered |
Johnson & Johnson 2015-02-27 |