| Primary Device ID | 00850078396129 |
| NIH Device Record Key | 661e3546-dd5e-4bc4-aa77-4fd8479ab884 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TransLoc 3D, Depth Gauge for All-Metal Introducer |
| Version Model Number | 1030 |
| Catalog Number | 1030 |
| Company DUNS | 084330422 |
| Company Name | Eca Medical Instruments |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850078396129 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-29 |
| Device Publish Date | 2026-01-21 |
| 00850078396129 - TransLoc 3D, Depth Gauge for All-Metal Introducer | 2026-01-29 |
| 00850078396129 - TransLoc 3D, Depth Gauge for All-Metal Introducer | 2026-01-29 |
| 00850078396143 - Invictus Power FT, 110in-lb/12.4Nm | 2026-01-13 |
| 00850078396075 - Arsenal Foot™ Bone Harvesting Kit, Ø 8.0mm | 2025-12-26 |
| 00850078396136 - iFuse INTRA Keystone Instrument Kit | 2025-12-25 |
| 00850078396280 - TRAQ Single Use Instrument Kit | 2025-12-22 |
| 00850078396112 - TransLoc 3D, 18” Wire and Measurement Guide | 2025-11-25 |
| 00850078396006 - MIS Bunion - Elevator (47-0030-S) | 2025-11-19 |
| 00850078396013 - MIS Bunion Accessory Kit (47-0028-S) | 2025-11-19 |