canturio™te Impaction Sleeve

GUDID 00850015699061

The Impaction Sleeve is a reusable (provided non-sterile), surgical instrument used to assist in attaching the CTE implant to the Zimmer Biomet Persona® Tibial Baseplate. The Impaction Sleeve protects the implant’s electronic components from impaction forces that occur during assembly.

Canary Medical USA LLC

Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor Orthopaedic implant impactor
Primary Device ID00850015699061
NIH Device Record Key70e1c526-00b6-48ae-95d1-cc922c8c98f7
Commercial Distribution StatusIn Commercial Distribution
Brand Namecanturio™te Impaction Sleeve
Version Model Number43-5399-001-14
Company DUNS117153396
Company NameCanary Medical USA LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850015699061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QPPImplantable Post-Surgical Kinematic Measurement Knee Device

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850015699061]

Moist Heat or Steam Sterilization


[00850015699061]

Moist Heat or Steam Sterilization


[00850015699061]

Moist Heat or Steam Sterilization


[00850015699061]

Moist Heat or Steam Sterilization


[00850015699061]

Moist Heat or Steam Sterilization


[00850015699061]

Moist Heat or Steam Sterilization


[00850015699061]

Moist Heat or Steam Sterilization


[00850015699061]

Moist Heat or Steam Sterilization


[00850015699061]

Moist Heat or Steam Sterilization


[00850015699061]

Moist Heat or Steam Sterilization


[00850015699061]

Moist Heat or Steam Sterilization


[00850015699061]

Moist Heat or Steam Sterilization


[00850015699061]

Moist Heat or Steam Sterilization


[00850015699061]

Moist Heat or Steam Sterilization


[00850015699061]

Moist Heat or Steam Sterilization


[00850015699061]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-30
Device Publish Date2021-09-22

Devices Manufactured by Canary Medical USA LLC

00850015699115 - CanarE Strap2023-05-25
00850015699122 - Canary Clinic Cart2023-05-25
00850015699139 - CanarE Charging Cradle2023-05-25
00860003118344 - CanarE – Clinic Wearable Device2023-05-25
00860003118368 - Canary Clinic Base Station2023-05-25
00860003118382 - Clinic Laptop2023-05-25
00850015699016 - OR Barcode Scanner2021-10-07 After the surgery is completed, the OR Barcode Scanner can be used to scan the barcodes on the labels of the CTE and other impla
00860003118337 - OR Laptop2021-10-07 Dedicated Laptop PC, part of the OR Base Station System

Trademark Results [canturio]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CANTURIO
CANTURIO
90603820 not registered Live/Pending
Canary Medical Inc.
2021-03-25
CANTURIO
CANTURIO
90211791 not registered Live/Pending
Canary Medical Inc.
2020-09-25

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