| Primary Device ID | 09350855000290 |
| NIH Device Record Key | 02935dfd-c8bf-46fc-ad73-7ec7fbe90254 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clean Ultrasound Probe Cover |
| Version Model Number | N00102 |
| Company DUNS | 741021943 |
| Company Name | NANOSONICS LIMITED |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09350855000290 [Primary] |
| GS1 | 09350855000405 [Unit of Use] |
| FFF | Cover, Biopsy Forceps |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-17 |
| Device Publish Date | 2019-07-09 |
| 09350855000740 - trophon3 | 2025-08-22 Contents: 1 x N05035-1 trophon3 10 x N05006 trophon AcuTrace Operator Card 10 X N05007 trophon AcuTrace Medical Instrument Tag |
| 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) |