| Primary Device ID | M595S4043 |
| NIH Device Record Key | 23b45f9d-94eb-41b9-ba23-94a5e2874802 |
| Commercial Distribution Discontinuation | 2019-01-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | TriPhasix™ |
| Version Model Number | S400 |
| Catalog Number | S400 |
| Company DUNS | 009900424 |
| Company Name | PARKELL, 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 | 6312491134 |
| customerservice@parkell.com |
| Special Storage Condition, Specify | Between 0 and 0 *Keep container tightly closed and store in a cool, dry and well-ventilated place. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep container tightly closed and store in a cool, dry and well-ventilated place. |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M595S4000 [Primary] |
| HIBCC | M595S4011 [Package] Contains: M595S4000 Package: [5 Units] Discontinued: 2019-01-01 Not in Commercial Distribution |
| HIBCC | M595S4022 [Package] Contains: M595S4000 Package: [10 Units] Discontinued: 2019-01-01 Not in Commercial Distribution |
| HIBCC | M595S4043 [Package] Contains: M595S4000 Package: [25 Units] Discontinued: 2019-01-01 Not in Commercial Distribution |
| ELW | Material, Impression |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-04-01 |
| Device Publish Date | 2016-09-23 |
| 30810000526155 | 1lb. TriPhasix™ Chromatic Alginate |
| M595S4043 | 1lb. TriPhasix™ Chromatic Alginate |
| 10810000526182 | Measuring Scoops TriPhasix™ Alginate (2 each) |
| 00810000528271 | Measuring Scoops TriPhasix™ Alginate |