| Primary Device ID | 00850017635777 |
| NIH Device Record Key | 7180938a-9086-4faa-a65c-1ef0fd95c3be |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Austin Medical, Inc |
| Version Model Number | AU-162-A |
| Catalog Number | AU-162-A |
| 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 | false |
| 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 | 00850017635777 [Primary] |
| LRO | General Surgery Tray |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-30 |
| Device Publish Date | 2025-12-22 |
| 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 |
| 00850067106265 | Local Anesthesia Tray |
| 00850067106234 | Basin Pack (Small Animal) |
| 00850067106067 | Foot Cover |
| 00850067106050 | Groin Cover |
| 00850067106012 | Blue OR Towel 18x54 |
| 00850017635982 | Probe Kit with conductivity Gel |
| 00850017635975 | Tray with Foam Pad |
| 00850017635968 | Shoulder Suspension Stocking |
| 00850017635951 | General Purpose Prove Cover |
| 00850017635913 | EGD Pack |
| 00850017635906 | Colon Kit |
| 00850017635791 | Colic Pack |
| 00850017635777 | Large Animal Minor Tray |
| 00850017635760 | General Pack (Small Animal) |
| 00850017635753 | Eye Drape Pack Ophtho |
| 00850017635722 | Eye Pack Ophtho |
| 00850017635715 | Drape Pack (Small Animal) |
| 00850017635708 | Colic Pack |
| 00850017635692 | Skin Prep |
| 00850017635685 | Minor Pack (Small Animal) |
| 00850017635678 | General Pack-Colic Resection Pack |
| 00850017635661 | Eye Pack |
| 00850017635654 | Hip Drape |
| 00850017635272 | Procedure Pack |
| 00850017635234 | MPT Derm MM Clinic Pack |
| 00850017635180 | Colic Decompression Simplex |