| Primary Device ID | 08806373580895 |
| NIH Device Record Key | 8399275f-f293-47e7-909d-2ae137bea408 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 4CIS® PINEHURST ANTERIOR CERVICAL PLATE SYSTEM |
| Version Model Number | 5932-1109 |
| Catalog Number | 5932-1109 |
| 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 | 08806373580895 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08806373580895]
Moist Heat or Steam Sterilization
[08806373580895]
Moist Heat or Steam Sterilization
[08806373580895]
Moist Heat or Steam Sterilization
[08806373580895]
Moist Heat or Steam Sterilization
[08806373580895]
Moist Heat or Steam Sterilization
[08806373580895]
Moist Heat or Steam Sterilization
[08806373580895]
Moist Heat or Steam Sterilization
[08806373580895]
Moist Heat or Steam Sterilization
[08806373580895]
Moist Heat or Steam Sterilization
[08806373580895]
Moist Heat or Steam Sterilization
[08806373580895]
Moist Heat or Steam Sterilization
[08806373580895]
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 |