| Primary Device ID | 00860013000394 |
| NIH Device Record Key | 3d22716c-b979-42d7-b95c-8f3e3682a2f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Isolation Device Mixed pack |
| Version Model Number | 00860013000394 |
| Catalog Number | 00860013000394 |
| Company DUNS | 007596766 |
| Company Name | Fistula Solution Corporation |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860013000394 [Primary] |
| EZS | Appliance, Colostomy, Disposable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-08 |
| Device Publish Date | 2023-11-30 |
| 00860013000394 - Isolation Device Mixed pack | 2023-12-08Convenience kit containing 1 each: • REF 00860013000301 Wound Crown® • REF 00860013000325 Fistula Funnel® • REF 00860013000318 Isolator Strip® |
| 00860013000394 - Isolation Device Mixed pack | 2023-12-08 Convenience kit containing 1 each: • REF 00860013000301 Wound Crown® • REF 00860013000325 Fistula Funnel® • REF 008600 |
| 00860013000301 - Wound Crown | 2022-08-29 |
| 10860013000315 - Isolator Strip | 2022-08-29 |
| 00860013000325 - Fistula Funnel | 2022-08-29 |