| Primary Device ID | 00860013905965 |
| NIH Device Record Key | 0467c8d4-456e-4ecc-8b88-3f4779559dc8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Integrity Orthopaedics |
| Version Model Number | 902001 |
| Catalog Number | 902001 |
| Company DUNS | 118804591 |
| Company Name | Integrity Orthopaedics, 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 | false |
| 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 |
| 00860009782228 | Integrity Orthopaedics Anchor Array System Kit |
| 00860009782211 | Integrity Orthopaedics Delivery Instrument, included with Anchor Array System Kit |
| 00860013905989 | Tendon Seam™ Magazine - 4 Anchor |
| 00860013905972 | Tendon Seam™ Instrument Kit - 4 Anchor |
| 00860013905965 | Delivery Instrument, included with Tendon Seam™ Instrument Kit - 4 Anchor |
| 00860013905958 | Tendon Seam™ Magazine - 4 Anchor, included with Tendon Seam™ Instrument Kit - 4 Anchor |
| 00860013905941 | Tendon Seam™ Magazine - 8 Anchor |
| 00860013905934 | Tendon Seam™ Instrument Kit - 8 Anchor |
| 00860013905927 | Delivery Instrument, included with Tendon Seam™ Instrument Kit - 8 Anchor |
| 00860013905910 | Tendon Seam™ Magazine - 8 Anchor, included with Tendon Seam™ Instrument Kit - 8 Anchor |