TRIWAY
GUDID 03760225717646
IN2BONES
Tibia nail| Primary Device ID | 03760225717646 |
| NIH Device Record Key | ddfc7058-12ea-42f9-899e-842556a10ff1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRIWAY |
| Version Model Number | N20 ST221 |
| Company DUNS | 263616749 |
| Company Name | IN2BONES |
| 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 |
Device Dimensions
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
| Length | 160 Millimeter |
| Outer Diameter | 12 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03760225717646 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K173811
FDA Product Code
| HSB | Rod, Fixation, Intramedullary And Accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-12-08 |
| Device Publish Date | 2019-03-01 |
On-Brand Devices [TRIWAY]
Trademark Results [TRIWAY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRIWAY 79154341 4702022 Live/Registered |
In2Bones 2014-06-04 |
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