| Primary Device ID | 20814247020745 |
| NIH Device Record Key | ba923297-1974-4d42-804c-301af2b67d64 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Goldtrace One |
| Version Model Number | CNS000008 |
| Company DUNS | 809524291 |
| Company Name | CLINICAL INNOVATIONS, LLC |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814247020741 [Primary] |
| GS1 | 10814247020748 [Package] Contains: 00814247020741 Package: [25 Units] In Commercial Distribution |
| GS1 | 20814247020745 [Package] Contains: 10814247020748 Package: [4 Units] In Commercial Distribution |
| HGP | Electrode, Circular (Spiral), Scalp And Applicator |
| 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 | 2016-09-01 |
| 10814247021196 - FSE | 2023-10-05 Fetal Spiral Electrode |
| 00814247021205 - FSE Cables | 2023-10-05 DECG Reusable Legplate Adapter Cable |
| 10814247020120 - babyLance | 2023-04-24 Preemie (Pink/White) 0.85 mm depth, Safety Heelstick |
| 10814247020168 - babyLance | 2023-04-24 Micropreemie (Yellow/Green) 0.60 mm depth, Safety Heelstick |
| 10814247020182 - babyLance | 2023-04-24 Newborn (Blue/Green) 1.0 mm depth, Safety Heelstick |
| 10814247021127 - ABBy | 2023-04-24 ABBy Panniculus Retractor - 05 Regular |
| 10814247021134 - ABBy | 2023-04-24 ABBy Panniculus Retractor - 05 Extra Large |
| 10814247021141 - ABBy | 2023-04-24 ABBy Panniculus Retractor - 10 Regular |