| Primary Device ID | 00385640000314 |
| NIH Device Record Key | 5ac95593-7860-401b-8ce7-fa00f92988a4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Epistax Balloon Catheter |
| Version Model Number | RH-4200-01 |
| Catalog Number | RH-4200-01 |
| Company DUNS | 965484699 |
| Company Name | SUMMIT MEDICAL, INC. |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00385640000314 [Primary] |
| GS1 | 10385640000311 [Package] Package: SHELF BOX [1 Units] In Commercial Distribution |
| EMX | Balloon, Epistaxis |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-17 |
| 00385640003483 | RH-4120-02 |
| 00385640003476 | RH-4120-01 |
| 00385640003469 | RH-4100-10 |
| 00385640003452 | RH-4100-01 |
| 00385640000369 | RH-4420-01 |
| 00385640000352 | RH-4400-10 |
| 00385640000345 | RH-4400-01 |
| 00385640000338 | RH-4220-01 |
| 00385640000321 | RH-4200-01 |
| 00385640000314 | RH-4200-01 |
| 00385640000253 | RC-4400 |
| 00385640000246 | RC-4200 |