Home GUDID 00850015699092 canturio™te Canary Tibial Ext 14x58mm X-Ray Template
Primary DI 00850015699092
Brand canturio™te Canary Tibial Ext 14x58mm X-Ray Template
Company Canary Medical USA LLC
Model 43-5570-004-14
Device description The CTE 14mm x 58mm X-Ray Template is a surgical instrument used to assist the surgeon during preoperative planning.
Published 2021-09-22
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name QPP Implantable Post-Surgical Kinematic Measurement Knee Device
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QPP Implantable Post-Surgical Kinematic Measurement Knee Device Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850015699092 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850015699092 00850015699092 850015699092 0850015699092
GMDN Terms# Term, Definition table Term Definition Surgical implant template, reusable A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 117153396 Device count 1 Lot or batch true Serial number true Expiration date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850015699115 CanarE Strap 43-5570-007-16 2023-05-17 00850015699061 canturio™te Impaction Sleeve 43-5399-001-14 2021-09-22 00860003118399 Canturio® Smart Extension 14mm (D) x 30mm (H) 43-5570-030-14 2024-09-12 00850015699153 Home Base Station (Bluetooth) 43-5570-001-15 2024-09-06 00850015699122 Canary Clinic Cart 43-5570-008-14 2023-05-17 00850015699139 CanarE Charging Cradle 43-5570-007-15 2023-05-17 00860003118344 CanarE – Clinic Wearable Device 43-5570-007-14 2023-05-17 00860003118368 Canary Clinic Base Station 43-5570-005-14 2023-05-17 00860003118382 Clinic Laptop 43-5570-003-15 2023-05-17 00850015699009 canturio™te Cemented Tibia Drill Bit 43-5399-058-14 2021-09-22 00850015699023 canturio™te Tibia Resection Cutting Guide, Left, 5 Deg. 43-5399-051-05 2021-09-22 00850015699054 canturio™te Tibia Resection Cutting Guide, Right, 5 Deg. 43-5399-052-05 2021-09-22 00850015699030 canturio™te Modular Bracket Stem Provisional 110043613 2021-09-22 00850015699047 canturio™te Modular Bracket Drill Bit 110043614 2021-09-22 00850015699078 canturio™te Modular Bracket Tibial Cutting Guide, Left; 5 Deg. 43-5907-080-27 2021-09-22 00850015699085 canturio™te Modular Bracket Tibial Cutting Guide, Right; 5 Deg. 43-5907-080-29 2021-09-22 00850015699108 canturio™ te Modular Bracket, Impaction Sleeve 110044505 2021-09-22 00860003118351 canturio™te Provisional 43-5571-058-14 2021-09-22 00860003118313 Canary OR Base Station / OR PC App / OR Registration 43-5570-002-14 2021-09-22 00860003118320 Canary Home Base Station 43-5570-001-14 2021-09-22
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860003118399 Canturio® Smart Extension 14mm (D) x 30mm (H) Canary Medical USA LLC QPP 2024-09-12 00850015699009 canturio™te Cemented Tibia Drill Bit Canary Medical USA LLC QPP 2021-09-22 00850015699023 canturio™te Tibia Resection Cutting Guide, Left, 5 Deg. Canary Medical USA LLC QPP 2021-09-22 00850015699030 canturio™te Modular Bracket Stem Provisional Canary Medical USA LLC QPP 2021-09-22 00850015699047 canturio™te Modular Bracket Drill Bit Canary Medical USA LLC QPP 2021-09-22 00850015699054 canturio™te Tibia Resection Cutting Guide, Right, 5 Deg. Canary Medical USA LLC QPP 2021-09-22 00850015699061 canturio™te Impaction Sleeve Canary Medical USA LLC QPP 2021-09-22 00850015699078 canturio™te Modular Bracket Tibial Cutting Guide, Left; 5 Deg. Canary Medical USA LLC QPP 2021-09-22 00850015699085 canturio™te Modular Bracket Tibial Cutting Guide, Right; 5 Deg. Canary Medical USA LLC QPP 2021-09-22 00850015699108 canturio™ te Modular Bracket, Impaction Sleeve Canary Medical USA LLC QPP 2021-09-22 00860003118306 canturio™te Canary Medical USA LLC QPP 2021-09-22 00860003118351 canturio™te Provisional Canary Medical USA LLC QPP 2021-09-22