| Primary Device ID | B3901441401 |
| NIH Device Record Key | ed4015ec-b574-41e6-b35c-a5da04cd8a47 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reprocessed Mako Bone Pins 4mm x 140mm |
| Version Model Number | 144140 |
| Company DUNS | 785616934 |
| Company Name | SURETEK MEDICAL |
| 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 | 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 | B3901441401 [Primary] |
| LXH | Orthopedic Manual 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 | 2024-10-02 |
| Device Publish Date | 2024-09-24 |
| B3901431401 - Reprocessed Mako Bone Pins 3.2mm x 140mm | 2024-10-02 |
| B3901441401 - Reprocessed Mako Bone Pins 4mm x 140mm | 2024-10-02 |
| B3901441401 - Reprocessed Mako Bone Pins 4mm x 140mm | 2024-10-02 |
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