| Primary Device ID | B562PK301ELB2000 |
| NIH Device Record Key | 669a78c3-147d-44e8-b65a-d1ff9204837d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | K-Wire |
| Version Model Number | PK-301-ELB200 |
| Company DUNS | 062355158 |
| Company Name | WISHBONE MEDICAL, 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 | true |
| 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | B562PK301ELB2000 [Primary] |
| HTY | Pin, Fixation, Smooth |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-24 |
| Device Publish Date | 2023-03-16 |
| B562PK301EXT1250 | Extremity Fracture Kit - 1.25mm |
| B562PK301ELB2000 | Elbow Fracture Kit - 2.00mm |
| B562PK301ELB1600 | Elbow Fracture Kit - 1.60mm |