| Primary Device ID | 00821925024106 |
| NIH Device Record Key | 139b18cd-f974-4b68-be23-19650cebfb5d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SHEEHY COLLAR BUTTON PACIFIC 127MM ID FLUOROPLASTIC |
| Version Model Number | 70141080 |
| Company DUNS | 007198742 |
| Company Name | Gyrus Acmi, Inc. |
| 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 | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1(800)262-3540 |
| xxx@xxx.xxx | |
| Phone | 1(800)262-3540 |
| xxx@xxx.xxx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821925024106 [Package] Contains: 00821925034549 Package: [6 Units] In Commercial Distribution |
| GS1 | 00821925034549 [Primary] |
| ETD | Tube, Tympanostomy |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-24 |
| 00821925020597 | Ventilate the middle ear subsequent to otitis media Elimiate fluid buildup in the middle ear whi |
| 00821925024106 | Ventilate the middle ear subsequent to otitis media Elimiate fluid buildup in the middle ear whi |