| Primary Device ID | 00860006776015 |
| NIH Device Record Key | b6761707-cf29-4a36-9861-60888a45de05 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ICONN Revolution Knotless Suture Anchor |
| Version Model Number | 355000 |
| Company DUNS | 055774745 |
| Company Name | ICONN ORTHOPEDICS LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860006776015 [Primary] |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00860006776015]
Radiation Sterilization
[00860006776015]
Radiation Sterilization
[00860006776015]
Radiation Sterilization
[00860006776015]
Radiation Sterilization
[00860006776015]
Radiation Sterilization
[00860006776015]
Radiation Sterilization
[00860006776015]
Radiation Sterilization
[00860006776015]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-25 |
| Device Publish Date | 2025-09-17 |
| 00860419000295 | 350000 |
| 00860006776015 | 355000 |