FDA.reportPublic FDA data

trophon AcuTrace Medical Instrument Tag

Primary DI
09350855000214
Brand
trophon AcuTrace Medical Instrument Tag
Company
NANOSONICS LIMITED
Model
N05007
Device description
RFID Medical Instrument tag
Published
2018-06-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
09350855000214PrimaryGS10
09350855000283Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09350855000214093508550002149350855000214
09350855000283093508550002839350855000283

GMDN Terms#

Term, Definition table
TermDefinition
Device operating status label/tag, reusableA label or a tag intended to indicate the operating/calibration status (e.g., calibrated, repair required, out of service) and/or sterility record of the device to which it is attached; it does not include any additional functionality and does not include a sterilization process indicator. It is typically constructed from a durable material and may be designed to a specific standard. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
741021943
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09350855001068CORIS Adaptor Reprocessing HubN055392026-08-14
09350855000009Trophon EPRN00010-US2016-09-21
09350855000016Trophon EPRN00010-NNA2016-09-21
09350855000023Sonex-HLN000372016-09-21
09350855000030Sonex-HLN00037-NNA2016-09-21
09350855000122Trophon EPRN00010-US-RFB2016-09-21
09350855000559trophon Curved Probe PositionerN00099N000992022-07-08
09350855001037trophon2 RefurbishedN05000-1R2025-11-01
09350855000740trophon3N05035-US2025-08-14
09350855000542trophon Chemical IndicatorN05003N050032022-05-12
09350855000047Trophon Chemical IndicatorN000912016-09-21
09350855000054Trophon Chemical IndicatorN00091-NNA2016-09-21
09350855000184trophon2N05000-12018-06-15
09350855000177trophon Chemical IndicatorN050032018-06-15
09350855000849CORIS Smart Drain Adaptor OAN055212026-05-20
09350855000580CORIS QUANTUM Cleaning AgentN055032026-05-20
09350855000818CORIS Device EngineN055162026-05-20
09350855000832CORIS Adaptor O1N055172026-05-20
09350855000856CORIS Smart DrainN055202026-05-20
09350855000863CORIS Maintenance KitN055222026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826921209PENTAX MedicalPENTAX MEDICAL CORPORATIONOUG2026-08-25
00850015699160Canary Flight PlanCanary Medical USA LLCOUG2026-08-07
00850015699177Canary Recovery CurveCanary Medical USA LLCOUG2026-08-07
04048675544227Connectivity Converter CC300Drägerwerk AG & Co. KGaAOUG2026-07-17
04260658860258myoncareONCARE GmbHOUG2026-07-17
00840241600443Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-07-16
00884400004871GoClinicMonitored Therapeutics, Inc.OUG2026-07-16
00884400085481GoMobileMonitored Therapeutics, Inc.OUG2026-07-16
04035479194192PatientApp 2.10.0BIOTRONIK SE & Co. KGOUG2026-07-16
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
04048675558552Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558569Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558576Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675663997Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
07613327632811MaistroSTRYKER CORPORATIONOUG2025-10-10
00763000191887N/AMEDTRONIC, INC.OUG2025-09-05
00763000292102N/AMEDTRONIC, INC.OUG2025-09-05
00841492105671ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105688ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105695ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105701ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105718ResponderRAULAND-BORG CORPORATIONOUG2025-06-24
00841492105725ResponderRAULAND-BORG CORPORATIONOUG2025-06-24