| Primary Device ID | 00810000528271 |
| NIH Device Record Key | f0600143-9390-4363-9f11-412269620ea3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TriPhasix™ |
| Version Model Number | S408 |
| Catalog Number | S408 |
| 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 | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 631-249-1134 |
| customerservice@parkell.com | |
| Phone | 631-249-1134 |
| customerservice@parkell.com | |
| Phone | 631-249-1134 |
| customerservice@parkell.com | |
| Phone | 631-249-1134 |
| customerservice@parkell.com | |
| Phone | 631-249-1134 |
| customerservice@parkell.com | |
| Phone | 631-249-1134 |
| customerservice@parkell.com | |
| Phone | 631-249-1134 |
| customerservice@parkell.com | |
| Phone | 631-249-1134 |
| customerservice@parkell.com | |
| Phone | 631-249-1134 |
| customerservice@parkell.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000528271 [Primary] |
| ELW | Material, Impression |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-10-06 |
| Device Publish Date | 2025-09-26 |
| 30810000526155 | 1lb. TriPhasix™ Chromatic Alginate |
| M595S4043 | 1lb. TriPhasix™ Chromatic Alginate |
| 10810000526182 | Measuring Scoops TriPhasix™ Alginate (2 each) |
| 00810000528271 | Measuring Scoops TriPhasix™ Alginate |