| Primary Device ID | 00854763006089 |
| NIH Device Record Key | e9ef58f0-dbff-4d4a-9bcb-384bdae2c747 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Guidance handpiece |
| Version Model Number | 5300 |
| Catalog Number | 5300 |
| Company DUNS | 602783495 |
| Company Name | HALT MEDICAL, INC |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854763006089 [Primary] |
| HFG | Coagulator, Laparoscopic, Unipolar (And Accessories) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-19 |
| 00854763006003 - Handpiece | 2018-03-29 Disposable handpiece used for deliver RF energy to a target tissue. |
| 00854763006010 - Pads | 2018-03-29 Dispersive pad connects to the generator |
| 00854763006027 - Handpiece cable | 2018-03-29 Cable connects the handpiece to the generator |
| 00854763006034 - Generator | 2018-03-29 RF Generator |
| 00854763006041 - Guidance controller | 2018-03-29 Guidance magnetic tracking controller |
| 00854763006058 - Guidance ultrasound transducer sleeve | 2018-03-29 Sterile Disposable Guidance Ultrasound Transducer Sleeve |
| 00854763006065 - Guidance field generator | 2018-03-29 The Table Top Field Generator (TTFG) generates a magnetic field that is picked up by the magnetic guidance sensors |
| 00854763006072 - Pad cable | 2018-03-29 Cable connects the pads to the generator |