| Primary Device ID | 00818614022468 |
| NIH Device Record Key | ff5f0563-cd5c-4dd2-a8b5-bbde04ae6b48 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SSA |
| Version Model Number | DS-1610 |
| Company DUNS | 117630237 |
| Company Name | Maruho Medical, Inc. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818614022468 [Primary] |
| GS1 | 10818614022465 [Package] Package: box [10 Units] In Commercial Distribution |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-12 |
| Device Publish Date | 2021-07-02 |
| 00818614022468 | 16mm Distraction Screw |
| 00818614022451 | 14mm Distraction Screw |
| 00818614022444 | 12mm Distraction Screw |