| Primary Device ID | G426TI02000 |
| NIH Device Record Key | 70fb4391-d4a8-455c-a5bd-ebb567547f31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stone Instruments Co |
| Version Model Number | TI-0200 |
| Catalog Number | TI-0200 |
| Company DUNS | 645446428 |
| Company Name | STONE INSTRUMENTS CO |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G426TI02000 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[G426TI02000]
Moist Heat or Steam Sterilization
[G426TI02000]
Moist Heat or Steam Sterilization
[G426TI02000]
Moist Heat or Steam Sterilization
[G426TI02000]
Moist Heat or Steam Sterilization
[G426TI02000]
Moist Heat or Steam Sterilization
[G426TI02000]
Moist Heat or Steam Sterilization
[G426TI02000]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-26 |
| Device Publish Date | 2026-01-17 |
| G426KLTR030422M0 | TIWANA BONE CLAMP MEDIUM |
| G426KLTR030422L0 | TIWANA BONE CLAMP LARGE |
| G426TI02000 | McCulloch Type Hinged Retractor |