| Primary Device ID | 00850000126039 |
| NIH Device Record Key | 48ab030b-0970-442d-9981-cdf009f169a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HEAD & NECK PRESSURE DRESSING |
| Version Model Number | S-1010-2 |
| Company DUNS | 059817742 |
| Company Name | Oto-Med, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(866)472-2363 |
| info@gracemedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850000126039 [Primary] |
| GS1 | 10850000126036 [Package] Package: [6 Units] In Commercial Distribution |
| MHW | Dressing, Compression |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-03-13 |
| Device Publish Date | 2018-09-21 |
| 10850000126166 - CI UNIVERSAL DRAPE | 2021-11-29 CI UNIVERSAL DRAPE |
| 10850000126159 - LEVINE IRRIGATION-SUCTION TUBING | 2021-02-08 LEVINE IRRIGATION-SUCTION TUBING |
| 10850000126135 - EAR DRESSING, ADULT | 2020-12-08 EAR DRESSING, ADULT |
| 10850000126142 - EAR DRESSING, PEDIATRIC | 2020-12-08 EAR DRESSING, PEDIATRIC |
| 00850000126015 - GLASSCOCK® EAR DRESSING, ADULT | 2020-03-13 GLASSCOCK® EAR DRESSING, ADULT |
| 00850000126022 - GLASSCOCK® EAR DRESSING, PEDIATRIC | 2020-03-13 GLASSCOCK® EAR DRESSING, PEDIATRIC |
| 00850000126039 - HEAD & NECK PRESSURE DRESSING | 2020-03-13HEAD & NECK PRESSURE DRESSING |
| 00850000126039 - HEAD & NECK PRESSURE DRESSING | 2020-03-13 HEAD & NECK PRESSURE DRESSING |
| 00850000126121 - OTOMED® SUCTION TUBING | 2019-10-07 OTOMED® SUCTION TUBING |