| Primary Device ID | 08806373580796 | 
| NIH Device Record Key | f80c11af-a409-4556-8f80-f167ed952bd4 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | 4CIS® PINEHURST ANTERIOR CERVICAL PLATE SYSTEM | 
| Version Model Number | 5932-1119 | 
| Catalog Number | 5932-1119 | 
| Company DUNS | 687844241 | 
| Company Name | ALPHANOX 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 | true | 
| Serial Number | false | 
| Manufacturing Date | true | 
| Expiration Date | false | 
| 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 | 
|---|---|
| GS1 | 08806373580796 [Primary] | 
| LXH | Orthopedic Manual Surgical Instrument | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[08806373580796]
Moist Heat or Steam Sterilization
[08806373580796]
Moist Heat or Steam Sterilization
[08806373580796]
Moist Heat or Steam Sterilization
[08806373580796]
Moist Heat or Steam Sterilization
[08806373580796]
Moist Heat or Steam Sterilization
[08806373580796]
Moist Heat or Steam Sterilization
[08806373580796]
Moist Heat or Steam Sterilization
[08806373580796]
Moist Heat or Steam Sterilization
[08806373580796]
Moist Heat or Steam Sterilization
[08806373580796]
Moist Heat or Steam Sterilization
[08806373580796]
Moist Heat or Steam Sterilization
[08806373580796]
Moist Heat or Steam Sterilization
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2024-10-29 | 
| Device Publish Date | 2019-01-24 | 
| 08806373581472 | 4CIS® Pinehurst Plate Holder | 
| 08806373581229 | 4CIS® Pinehurst Single DTS | 
| 08806373581212 | 4CIS® Pinehurst Double DTS | 
| 08806373580895 | 4CIS® Pinehurst Drill 16mm | 
| 08806373580888 | 4CIS® Pinehurst Drill 14mm | 
| 08806373580871 | 4CIS® Pinehurst Drill 12mm | 
| 08806373580864 | 4CIS® Pinehurst Drill 10mm | 
| 08806373580840 | 4CIS® Pinehurst Plate Bender | 
| 08806373580796 | 4CIS® Pinehurst Self Constrained Awl | 
| 08806373580789 | 4CIS® Pinehurst Hexlobe Screw Removal Tool | 
| 08806373580772 | 4CIS® Pinehurst Temporary Fixation Pin Inserter | 
| 08806373580765 | 4CIS® Pinehurst Screw Driver | 
| 08806373580758 | 4CIS® Pinehurst Drill Guide-Variable | 
| 08806373580741 | 4CIS® Pinehurst Drill Guide-Fixed | 
| 08806373580727 | 4CIS® Pinehurst Tap 10mm |