| Primary Device ID | 00850017635876 |
| NIH Device Record Key | 7141f911-2e5c-4b1a-a54a-a6c12df54d8c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Austin Medical, Inc |
| Version Model Number | AU-209S |
| Catalog Number | AU-209S |
| Company DUNS | 010058700 |
| Company Name | AUSTIN MEDICAL |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850017635876 [Primary] |
| LRO | General Surgery Tray |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-11-26 |
| Device Publish Date | 2025-10-29 |
| 00850017635999 | WTR Sol Myelogram Tray |
| 00850017635876 | OSU Veterinary Arthroscopy Tray |
| 00850017635852 | Pain Tray |
| 00850017635838 | Cataract Pack |
| 00850017635821 | Myelogram Tray |
| 00850017635807 | Pain Tray |
| 00850017635784 | Myelogram Tray |
| 00850017635630 | Breast Localization |
| 00850017635623 | Arthrogram Tray |
| 00850017635616 | Custom Arthrogram Tray |
| 00850017635609 | Biopsy Tray |
| 00850017635586 | CT Biopsy Tray |
| 00850017635579 | Minor Biopsy Tray |
| 00850017635555 | Standard Biopsy Tray |
| 00850017635548 | CT Biopsy Tray |
| 00850017635531 | Arthrogram Tray |
| 00850017635524 | Nerve Block Tray |