Primary Device ID | 03662663041393 |
NIH Device Record Key | d7d05d87-c67d-4ebf-8ce9-dd789dfa172c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ROI-T |
Version Model Number | IR9091R |
Catalog Number | IR9091R |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03662663041393 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
[03662663041393]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2022-03-10 |
Device Publish Date | 2018-12-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ROI-T 77288500 3573547 Dead/Cancelled |
ZIMMER BIOMET SPINE, INC. 2007-09-25 |