Primary Device ID | TKRL0000FI105 |
NIH Device Record Key | 45a5e7a2-eab2-4f6a-8f99-8b8f9cc52f27 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PointCloud |
Version Model Number | UKI0101-L |
Company DUNS | 118205691 |
Company Name | Unik Orthopedics Inc. |
Device Count | 1 |
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 | false |
Serial Number | true |
Manufacturing Date | true |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | TKRL0000FI105 [Primary] |
MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
Steralize Prior To Use | true |
Device Is Sterile | false |
[TKRL0000FI105]
Moist Heat or Steam Sterilization
[TKRL0000FI105]
Moist Heat or Steam Sterilization
[TKRL0000FI105]
Moist Heat or Steam Sterilization
[TKRL0000FI105]
Moist Heat or Steam Sterilization
[TKRL0000FI105]
Moist Heat or Steam Sterilization
[TKRL0000FI105]
Moist Heat or Steam Sterilization
[TKRL0000FI105]
Moist Heat or Steam Sterilization
[TKRL0000FI105]
Moist Heat or Steam Sterilization
[TKRL0000FI105]
Moist Heat or Steam Sterilization
[TKRL0000FI105]
Moist Heat or Steam Sterilization
[TKRL0000FI105]
Moist Heat or Steam Sterilization
[TKRL0000FI105]
Moist Heat or Steam Sterilization
[TKRL0000FI105]
Moist Heat or Steam Sterilization
[TKRL0000FI105]
Moist Heat or Steam Sterilization
[TKRL0000FI105]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-10-31 |
Device Publish Date | 2022-10-22 |
TKRR0000LID65 | UNIKO PointCloud™ Knee Instrument Kit Right |
TKRR0000LI745 | UNIKO PointCloud™ Knee Instrument Kit Right |
TKRR0000LI105 | UNIKO PointCloud™ Knee Instrument Kit Right |
TKRR0000LD2D5 | UNIKO PointCloud™ Knee Instrument Kit Right |
TKRR0000LB3B5 | UNIKO PointCloud™ Knee Instrument Kit Right |
TKRR0000L6855 | UNIKO PointCloud™ Knee Instrument Kit Right |
TKRR0000L6265 | UNIKO PointCloud™ Knee Instrument Kit Right |
TKRR0000L5K05 | UNIKO PointCloud™ Knee Instrument Kit Right |
TKRR0000L4F85 | UNIKO PointCloud™ Knee Instrument Kit Right |
TKRR0000FK065 | UNIKO PointCloud™ Knee Instrument Kit Right |
TKRR0000FI7I5 | UNIKO PointCloud™ Knee Instrument Kit Right |
TKRR0000FF8D5 | UNIKO PointCloud™ Knee Instrument Kit Right |
TKRR0000FF295 | UNIKO PointCloud™ Knee Instrument Kit Right |
TKRR0000FB3F5 | UNIKO PointCloud™ Knee Instrument Kit Right |
TKRR0000F4995 | UNIKO PointCloud™ Knee Instrument Kit Right |
TKRR0000F17L5 | UNIKO PointCloud™ Knee Instrument Kit Right |
TKRR0000DFL65 | UNIKO PointCloud™ Knee Instrument Kit Right |
TKRR0000DF825 | UNIKO PointCloud™ Knee Instrument Kit Right |
TKRL0000LL595 | UNIKO PointCloud™ Knee Instrument Kit Left |
TKRL0000LK015 | UNIKO PointCloud™ Knee Instrument Kit Left |
TKRL0000LF225 | UNIKO PointCloud™ Knee Instrument Kit Left |
TKRL0000LDF45 | UNIKO PointCloud™ Knee Instrument Kit Left |
TKRL0000LBI35 | UNIKO PointCloud™ Knee Instrument Kit Left |
TKRL0000L6F15 | UNIKO PointCloud™ Knee Instrument Kit Left |
TKRL0000L55K5 | UNIKO PointCloud™ Knee Instrument Kit Left |
TKRL0000L3D05 | UNIKO PointCloud™ Knee Instrument Kit Left |
TKRL0000FLK35 | UNIKO PointCloud™ Knee Instrument Kit Left |
TKRL0000FKD15 | UNIKO PointCloud™ Knee Instrument Kit Left |
TKRL0000FK6D5 | UNIKO PointCloud™ Knee Instrument Kit Left |
TKRL0000FID95 | UNIKO PointCloud™ Knee Instrument Kit Left |
TKRL0000FI105 | UNIKO PointCloud™ Knee Instrument Kit Left |
TKRL0000FFLL5 | UNIKO PointCloud™ Knee Instrument Kit Left |
TKRL0000FDFI5 | UNIKO PointCloud™ Knee Instrument Kit Left |
TKRL0000FD945 | UNIKO PointCloud™ Knee Instrument Kit Left |
TKRL0000FD355 | UNIKO PointCloud™ Knee Instrument Kit Left |
TKRL0000F8845 | UNIKO PointCloud™ Knee Instrument Kit Left |
TKRL0000F5635 | UNIKO PointCloud™ Knee Instrument Kit Left |
TKRL0000F30I5 | UNIKO PointCloud™ Knee Instrument Kit Left |
TKRL0000F1L25 | UNIKO PointCloud™ Knee Instrument Kit Left |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() POINTCLOUD 85589655 4441575 Live/Registered |
13th Lab AB 2012-04-05 |