| Primary Device ID | 00866001000315 |
| NIH Device Record Key | 0252c27d-a581-4557-8a78-de210075f45e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Austin Medical |
| Version Model Number | AU-0984SC |
| Catalog Number | AU-0984SC |
| Company DUNS | 010058700 |
| Company Name | AUSTIN MEDICAL |
| 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 | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00866001000308 [Primary] |
| GS1 | 00866001000315 [Package] Contains: 00866001000308 Package: Case [10 Units] In Commercial Distribution |
| KKX | Drape, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-11-08 |
| Device Publish Date | 2016-12-09 |
| 00850017635456 - Austin Medical, Inc. | 2022-01-18 Protego Pro Kit |
| 00866001000360 - Austin Medical, Inc. | 2021-12-17 Hemorrhage View C-section Drape |
| 00850017635425 - Austin | 2021-04-14 Mother’s Viewing Drape with Bleed ID Window |
| 00866001000315 - Austin Medical | 2018-11-08Mother’s Viewing Drape - C-Section-sterile |
| 00866001000315 - Austin Medical | 2018-11-08 Mother’s Viewing Drape - C-Section-sterile |
| 10866001000329 - Clear Horizon | 2018-11-08 "24"" x 24"" SMS Eye Drape w/ 1 fluid control pouch & 4"" x 5"" w/ Incise" |
| 00866001000346 - Austin | 2018-07-09 Total Capture Hysteroscopy Drape |