FDA.reportPublic FDA data

OR Barcode Scanner

Primary DI
00850015699016
Brand
OR Barcode Scanner
Company
Canary Medical USA LLC
Model
43-5570-006-14
Device description
After the surgery is completed, the OR Barcode Scanner can be used to scan the barcodes on the labels of the CTE and other implanted TKA components.
Published
2021-09-29
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
CodeName
OUGMedical Device Data System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850015699016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850015699016008500156990168500156990160850015699016

GMDN Terms#

Term, Definition table
TermDefinition
Patient health record information systemA dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. The system typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117153396
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850015699115CanarE Strap43-5570-007-162023-05-17
00850015699061 canturio™te Impaction Sleeve43-5399-001-142021-09-22
00860003118399Canturio® Smart Extension 14mm (D) x 30mm (H)43-5570-030-142024-09-12
00850015699153Home Base Station (Bluetooth)43-5570-001-152024-09-06
00850015699122Canary Clinic Cart43-5570-008-142023-05-17
00850015699139CanarE Charging Cradle43-5570-007-152023-05-17
00860003118344CanarE – Clinic Wearable Device43-5570-007-142023-05-17
00860003118368Canary Clinic Base Station43-5570-005-142023-05-17
00860003118382Clinic Laptop43-5570-003-152023-05-17
00850015699009 canturio™te Cemented Tibia Drill Bit43-5399-058-142021-09-22
00850015699023 canturio™te Tibia Resection Cutting Guide, Left, 5 Deg.43-5399-051-052021-09-22
00850015699054 canturio™te Tibia Resection Cutting Guide, Right, 5 Deg.43-5399-052-052021-09-22
00850015699030 canturio™te Modular Bracket Stem Provisional1100436132021-09-22
00850015699047 canturio™te Modular Bracket Drill Bit1100436142021-09-22
00850015699078 canturio™te Modular Bracket Tibial Cutting Guide, Left; 5 Deg.43-5907-080-272021-09-22
00850015699085 canturio™te Modular Bracket Tibial Cutting Guide, Right; 5 Deg.43-5907-080-292021-09-22
00850015699108canturio™ te Modular Bracket, Impaction Sleeve1100445052021-09-22
00860003118351 canturio™te Provisional43-5571-058-142021-09-22
00860003118313Canary OR Base Station / OR PC App / OR Registration43-5570-002-142021-09-22
00860003118320Canary Home Base Station43-5570-001-142021-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150006038N/AMEDTRONIC, INC.OUG2026-05-23
04931921049464NANIHON KOHDEN CORPORATIONOUG2026-05-20
04931921111697NANIHON KOHDEN CORPORATIONOUG2026-05-20
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
05404028001158Mimics FlowMaterialise NVOUG2026-03-23
05404028001172SurgiCase OnlineMaterialise NVOUG2026-03-23
05404028001189ProPlan CMF Materialise NVOUG2026-03-23
00763000994914NAMEDTRONIC, INC.OUG2026-03-22
00382904450106BD Veritor™ InfoWiFi ModuleBECTON, DICKINSON AND COMPANYOUG2026-03-13
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
04035479189211PatientApp 2.9BIOTRONIK SE & Co. KGOUG2026-03-04
07350149360033PD Care SystemPainDrainer ABOUG2026-03-04
00860015454706RocotoRocoto Inc.OUG2026-02-26
00860015454713RocotoRocoto Inc.OUG2026-02-26
00860015454720RocotoRocoto Inc.OUG2026-02-26
00860015454737RocotoRocoto Inc.OUG2026-02-26
00860015454768RocotoRocoto Inc.OUG2026-02-26
00860015454775RocotoRocoto Inc.OUG2026-02-26
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
00199150002184NAMEDTRONIC, INC.OUG2026-02-01
03770034761006LIMSTARHOPI MEDICALOUG2026-01-28
03770034761013MINILIMHOPI MEDICALOUG2026-01-28
03770034761020FMCHOPI MEDICALOUG2026-01-28