Primary Device ID | 00628184519004 |
NIH Device Record Key | 8c9de0c1-59a9-4b65-a7e1-6f7507ffdbb7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | intellijoint KNEE(R) |
Version Model Number | 000-0519 |
Company DUNS | 202958070 |
Company Name | Intellijoint Surgical Inc |
Device Count | 2 |
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 | 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 | 15193423178 |
info@intellijointsurgical.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00628184519004 [Primary] |
GS1 | 90628184005197 [Unit of Use] |
OLO | Orthopedic Stereotaxic Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00628184519004]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2020-03-09 |
Device Publish Date | 2019-12-06 |
00628184005668 - intellijoint KNEE® | 2022-01-18 Rotational Sizer Interface |
00628184005590 - intellijoint KNEE® | 2021-03-02 Probe Adaptor 1.3 - 1.4mm |
00628184005606 - intellijoint KNEE® | 2021-03-02 Probe Adaptor 1.5 - 1.6mm |
00628184005613 - intellijoint KNEE® | 2021-03-02 Probe Adaptor 1.7 - 1.8mm |
00628184002810 - intellijoint navigation system | 2020-07-15 Camera, USB, G2 |
00628184004012 - intellijoint HIP® | 2020-07-15 Angled Probe |
00628184003930 - intellijoint HIP® | 2020-06-17 Pelvic Platform, Mini |
00628184002704 - intellijoint HIP® | 2020-04-01 Arm, Camera Mount, Magnetic Base |