| Primary Device ID | 00818614021355 |
| NIH Device Record Key | 927e66b8-a1c1-4d48-b91b-bbb65004a00f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Apollo Medial with needles |
| Version Model Number | 27-11145 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818614021355 [Primary] |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-09 |
| Device Publish Date | 2022-09-01 |
| 00818614021379 - Apollo | 2024-06-05 Medial Suture Anchor with Needles, PEEK |
| 10818614022595 - Disposable Punch, 6.5 mm | 2024-06-05 Disposable Punch, 6.5 mm Pouch |
| 00818614022635 - ABS Med Distraction Pin | 2023-09-06 ABS Med Distraction Pin , 12MM Pouch |
| 10818614022649 - ABS Med Distraction Pin | 2023-09-06 ABS Med Distraction Pin, 14MM Patient (Inner) |
| 10818614021406 - Distraction Screw | 2023-06-02 Distraction Screw, 12MM Patient (Inner) |
| 10818614021413 - Distraction Screw | 2023-06-02 Distraction Screw, 14MM Patient (Inner) |
| 10818614022601 - Distraction Pin, 12MM pouch | 2023-06-02 Sharp Distraction Pin, 12MM pouch |
| 10818614022618 - Distraction Pin, 14MM pouch | 2023-06-02 Sharp Distraction Pin, 14MM pouch |