| Primary Device ID | 00840096207606 |
| NIH Device Record Key | e9127a6f-915a-411a-9a7c-1cfaf5f3f28f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DEX TIPS™ Universal Handle |
| Version Model Number | CV-Handle |
| Company DUNS | 007883297 |
| Company Name | KATALYST SURGICAL LLC |
| 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 | false |
| Lot Batch | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840096207606 [Primary] |
| FZX | Guide, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840096207606]
Moist Heat or Steam Sterilization
[00840096207606]
Moist Heat or Steam Sterilization
[00840096207606]
Moist Heat or Steam Sterilization
[00840096207606]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2026-01-12 |
| Device Publish Date | 2020-06-08 |