| Primary Device ID | 10816959021877 |
| NIH Device Record Key | 11647baf-f0e3-43e1-826f-fd68dfb54aed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dornier Thulio Performance Fiber |
| Version Model Number | 200um Single-Use Fiber |
| Catalog Number | K2016360 |
| Company DUNS | 079295103 |
| Company Name | INNOVAQUARTZ LLC |
| 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 | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com | |
| Phone | 844-776-3539 |
| info@proflexfibers.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816959021870 [Primary] |
| GS1 | 10816959021877 [Package] Contains: 00816959021870 Package: Carton [3 Units] In Commercial Distribution |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-02 |
| Device Publish Date | 2025-04-24 |
| 10816959021884 | 200um Reusable Fiber |
| 10816959021877 | 200um Single-Use Fiber |