Home GUDID TKRL0000L55K5 PointCloud
Primary DI TKRL0000L55K5
Brand PointCloud
Company Unik Orthopedics Inc.
Model UKI0101-L
Device description UNIKO PointCloud™ Knee Instrument Kit Left
Published 2022-10-22
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status TKRL0000L55K5 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Total knee prosthesis implantation guide-instrument kit A collection of sterile hand-held surgical instruments intended to be used during total knee arthroplasty (TKA), either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. Components may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components; the implant is not included. This is a single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 118205691 Device count 1 Serial number true Manufacturing date on label true Expiration date on label true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840097536729 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536736 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536743 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536750 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536767 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536774 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536804 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536811 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 E31442411410 Signature Materialise NV MBH 2026-09-24 E31442422415 Signature Materialise NV MBH 2026-09-24 E31442422450 Signature Materialise NV MBH 2026-09-24 E31442422451 Signature Materialise NV MBH 2026-09-24 E31442422452 Signature Materialise NV MBH 2026-09-24 E31442422453 Signature Materialise NV MBH 2026-09-24 E31442422455 Signature Materialise NV MBH 2026-09-24 E31442422456 Signature Materialise NV MBH 2026-09-24 E31442422457 Signature Materialise NV MBH 2026-09-24 E31442422458 Signature Materialise NV MBH 2026-09-24 E31442422460 Signature Materialise NV MBH 2026-09-24 E31442422461 Signature Materialise NV MBH 2026-09-24 E31442422462 Signature Materialise NV MBH 2026-09-24 E31442422463 Signature Materialise NV MBH 2026-09-24 E31442422465 Signature Materialise NV MBH 2026-09-24 E31442422466 Signature Materialise NV MBH 2026-09-24 E31442422467 Signature Materialise NV MBH 2026-09-24 E31442422468 Signature Materialise NV MBH 2026-09-24 E31442422470 Signature Materialise NV MBH 2026-09-24 E31442422471 Signature Materialise NV MBH 2026-09-24 E31442422472 Signature Materialise NV MBH 2026-09-24 E31442422473 Signature Materialise NV MBH 2026-09-24