| Primary Device ID | 08809986460417 |
| NIH Device Record Key | 5029d5c0-101a-4a75-bec8-b82f639b72e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CastleLoc Pectus Bar System Instrument Set |
| Version Model Number | PB05-1004 |
| Catalog Number | PB05-1004 |
| Company DUNS | 631159324 |
| Company Name | L&K BIOMED CO. ,LTD. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 08809986460417 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809986460417]
Moist Heat or Steam Sterilization
[08809986460417]
Moist Heat or Steam Sterilization
[08809986460417]
Moist Heat or Steam Sterilization
[08809986460417]
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 |
| 08809986460509 | Implant Case - Caddy (removal) |
| 08809986460493 | Implant Case - Caddy |
| 08809986460479 | Implant Case - Tray3 |
| 08809986460462 | Implant Case - Tray2 |
| 08809986460455 | Implant Case - Tray1 |
| 08809986460448 | Implant Case - Container |
| 08809986460431 | Implant Case - Cover |
| 08809986460424 | Basic Instrument Case - Screw Caddy |
| 08809986460417 | Basic Instrument Case - Lower tray |
| 08809986460387 | Basic Instrument Case - Cover |
| 08809986460288 | Bar template 17inch |
| 08809986460271 | Bar template 16.5inch |
| 08809986460264 | Bar template 16inch |
| 08809986460257 | Bar template 15.5inch |
| 08806344399679 | Sternum Elevation Screw 8 |
| 08806344399662 | Sternum Elevation Screw 8 |