ROI-T IR9028R
GUDID 03662663040662
LDR Spine Usa, Inc.
Bone file/rasp, manual| Primary Device ID | 03662663040662 |
| NIH Device Record Key | 5a15c2f6-f05b-42c5-b57f-3c3200f17bbe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ROI-T |
| Version Model Number | IR9028R |
| Catalog Number | IR9028R |
| 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 |
Customer Support Contacts
| 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 Dimensions
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
| Height | 15 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03662663040662 [Primary] |
FDA Product Code
| LXH | Orthopedic Manual Surgical Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
[03662663040662]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-03-10 |
| Device Publish Date | 2018-12-13 |
On-Brand Devices [ROI-T]
Trademark Results [ROI-T]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ROI-T 77288500 3573547 Dead/Cancelled |
ZIMMER BIOMET SPINE, INC. 2007-09-25 |
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