| Primary Device ID | 08809986460295 |
| NIH Device Record Key | 5105ea9f-3807-48d7-a6d8-a137cbd441a0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CastleLoc Pectus Bar System Instrument Set |
| Version Model Number | PB01-0019-01 |
| Catalog Number | PB01-0019-01 |
| Company DUNS | 631159324 |
| Company Name | L&K BIOMED CO. ,LTD. |
| 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 | false |
| 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 |
|---|---|
| GS1 | 08809986460295 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809986460295]
Moist Heat or Steam Sterilization
[08809986460295]
Moist Heat or Steam Sterilization
[08809986460295]
Moist Heat or Steam Sterilization
[08809986460295]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-19 |
| Device Publish Date | 2024-12-11 |
| 08809986460486 | Implant Case - Tray4 |
| 08809986460400 | Basic Instrument Case - Upper tray |
| 08809986460394 | Basic Instrument Case - Container |
| 08809986460370 | Rib Hump Compressor 5 |
| 08809986460363 | Rib Hump Compressor 4 |
| 08809986460356 | Rib Hump Compressor 3 |
| 08809986460349 | Rib Hump Compressor 2 |
| 08809986460332 | Rib Hump Compressor 1 |
| 08809986460325 | EZ Crane System 4 |
| 08809986460318 | EZ Crane System 3 |
| 08809986460301 | EZ Crane System 2 |
| 08809986460295 | EZ Crane System 1 |