| Primary Device ID | 03662663041362 |
| NIH Device Record Key | 3bfeb6d8-56a8-4309-8fd8-485fab071857 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ROI-T |
| Version Model Number | IR9083R |
| Catalog Number | IR9083R |
| Company DUNS | 615789729 |
| Company Name | LDR Spine Usa, Inc. |
| 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 | false |
| 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 |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com | |
| Phone | 800-699-3360 |
| custserv@ldrspine.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03662663041362 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
[03662663041362]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-05-07 |
| Device Publish Date | 2018-12-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ROI-T 77288500 3573547 Dead/Cancelled |
ZIMMER BIOMET SPINE, INC. 2007-09-25 |