| Primary Device ID | 09350855000160 |
| NIH Device Record Key | d311a195-0a26-43d6-b298-75e8b3315409 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | trophon Sonex-HL |
| Version Model Number | N05002 |
| Company DUNS | 741021943 |
| Company Name | NANOSONICS LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00935085500025 [Package] Contains: 09350855000146 Package: Inner Shipper [2 Units] In Commercial Distribution |
| GS1 | 09350855000146 [Primary] |
| GS1 | 09350855000153 [Package] Contains: 09350855000146 Package: Inner Shipper [6 Units] In Commercial Distribution |
| GS1 | 09350855000160 [Package] Contains: 09350855000153 Package: Outer Shipper [2 Units] In Commercial Distribution |
| GS1 | 09350855000252 [Package] Contains: 09350855000146 Package: Inner Shipper [2 Units] In Commercial Distribution |
| GS1 | 09350855000269 [Package] Contains: 09350855000252 Package: Outer Shipper [2 Units] In Commercial Distribution |
| OUJ | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-06-24 |
| Device Publish Date | 2018-06-15 |
| 09350855000573 - trophon Wireless Ultrasound Probe Holder | 2024-11-04 Contains the following devices: 1 trophon Wireless Ultrasound Probe Holder (UDI: 09350855000511) 1 trophon AcuTrace Medical Inst |
| 09350855000207 - trophon AcuTrace Operator Card | 2024-06-05 RFID Operator card |
| 09350855000214 - trophon AcuTrace Medical Instrument Tag | 2024-06-05 RFID Medical Instrument tag |
| 09350855000566 - trophon Curved Probe Positioner | 2022-07-18 Curved Probe Positioner |
| 09350855000542 - trophon Chemical Indicator | 2022-05-20 Chemical Indicator |
| 09350855000047 - Trophon Chemical Indicator | 2021-02-19 Easy Reader CI US2 Gen2 SP-P16 (GE VARIANT) |
| 09350855000054 - Trophon Chemical Indicator | 2021-02-19 Chemical Indicator US SP-P18 (NNA VARIANT) |
| 09350855000108 - Trophon EPR | 2020-09-09 Trophon EPR USA Variant AHECC 8419.20.00 (GE VARIANT) |