iASSIST ®
GUDID 00889024563643
Orthosoft Inc
Orthopaedic prosthesis implantation instrument, single-use| Primary Device ID | 00889024563643 |
| NIH Device Record Key | efa13639-620b-44f2-a3ae-4a5b93236ea0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iASSIST ® |
| Version Model Number | 20-8000-000-20 |
| Company DUNS | 205670032 |
| Company Name | Orthosoft 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 | 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024563643 [Primary] |
FDA Product Code
| LXH | Orthopedic Manual Surgical Instrument |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-26 |
| Device Publish Date | 2021-02-18 |
Devices Manufactured by Orthosoft Inc
| 00887868578915 - HAMMR™ | 2024-05-01 |
| 00887868557873 - ROSA® Shoulder | 2024-03-14 |
| 00887868557880 - ROSA® Shoulder | 2024-03-14 |
| 00887868557897 - ROSA® Shoulder | 2024-03-14 |
| 00887868557903 - ROSA® Shoulder | 2024-03-14 |
| 00887868557910 - ROSA® Shoulder | 2024-03-14 |
| 00887868558078 - ROSA® Shoulder | 2024-03-14 |
| 00887868558092 - ROSA® Shoulder | 2024-03-14 |
Trademark Results [iASSIST]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IASSIST 97595075 not registered Live/Pending |
Triangle Tube Phase III Co. 2022-09-16 |
 IASSIST 90696907 not registered Live/Pending |
Triangle Tube Phase III Co. 2021-05-07 |
 IASSIST 86299323 not registered Dead/Abandoned |
Stuart C. Irby Company 2014-06-03 |
 IASSIST 85705606 4351660 Live/Registered |
ZIMMER, INC. 2012-08-16 |
 IASSIST 85125219 4061255 Live/Registered |
AssistRX, Inc. 2010-09-08 |
 IASSIST 79101806 4103905 Dead/Cancelled |
SINTOKOGIO, LTD. 2011-07-19 |
 IASSIST 76609005 3510344 Dead/Cancelled |
Toshiba Medical Systems Corporation 2004-08-27 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.