| Primary Device ID | 08809986460431 |
| NIH Device Record Key | f1a999a4-0153-4061-be38-a32921a691ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CastleLoc Pectus Bar System Instrument Set |
| Version Model Number | PB05-8001 |
| Catalog Number | PB05-8001 |
| 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 | 08809986460431 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809986460431]
Moist Heat or Steam Sterilization
[08809986460431]
Moist Heat or Steam Sterilization
[08809986460431]
Moist Heat or Steam Sterilization
[08809986460431]
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 |
| 08809986460240 | Bar template 15inch |
| 08809986460233 | Bar template 14.5inch |
| 08809986460226 | Bar template 14inch |
| 08809986460219 | Bar template 13.5inch |
| 08809986460202 | Bar template 13inch |
| 08809986460196 | Bar template 12.5inch |
| 08809986460189 | Bar template 12inch |
| 08809986460172 | Bar template 11.5inch |
| 08809986460165 | Bar template 11inch |
| 08809986460158 | Bar template 10.5inch |
| 08809986460141 | Bar template 10inch |
| 08809986460134 | Bar template 9.5inch |
| 08809986460127 | Bar template 9inch |
| 08809986466334 | Connector Holder (Unified Thread) |
| 08809986466426 | Crane System Container Bottom Tray |
| 08809986466419 | Crane System Container Upper Tray |
| 08809986466402 | Crane System Container |
| 08809986466396 | Crane System Container Cover |
| 08809986466389 | Introducer Bar 400mm |
| 08809986466372 | Introducer Bar 300mm |
| 08809986466365 | End-Hole Lever Bender Curved |
| 08809986466358 | End-Hole Lever Bender Straight |
| 08809986466341 | Connector Holder (Buttress Thread) |
| 08809986466327 | In-Situ Bending Iron Curved B |
| 08809986466310 | In-Situ Bending Iron Curved A |
| 08809986466303 | In-Situ Bending Iron Straight |
| 08809986466297 | CastleLoc Crane System |
| 08809986479549 | Bar Distance Gauge |
| 08809986479532 | End-Hole Lever Bender Curved(Circle 2H) |
| 08809986479525 | End-Hole Lever Bender Straight(Circle 2H) |
| 08809986479518 | End-Hole Lever Bender Curved(Circle 1H) |
| 08809986479501 | End-Hole Lever Bender Straight(Circle 1H) |
| 08809986479495 | Bar Removal Gripper |
| 08809986479488 | Nut Final Tightening Driver Shaft |