| Primary Device ID | 10855152006038 |
| NIH Device Record Key | 37c8dd3e-e570-498a-8408-9a5194d230c3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RoG Rope |
| Version Model Number | 10-1341 |
| Company DUNS | 006254430 |
| Company Name | Rog Sports Medicine, Inc. |
| 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 | 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 | 00855152006031 [Primary] |
| GS1 | 10855152006038 [Package] Contains: 00855152006031 Package: Box [10 Units] In Commercial Distribution |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2018-06-13 |
| 00855152006048 - ROG Cuff Anchor | 2021-03-23 ROG 5.5mm Cuff Anchor w 3 x #2 UHMWPE suture |
| 10855152006038 - RoG Rope | 2019-02-07UHMWPE #2 Suture |
| 10855152006038 - RoG Rope | 2019-02-07 UHMWPE #2 Suture |
| 00855152006000 - RoG Cuff Anchor 5.5mm | 2018-07-06 5.5mm suture anchor with 2x 36" UHMWPE #2 suture |
| 10855152006014 - RoG 5.5mm Knotless Suture Anchor | 2018-07-06 RoG 5.5mm Knotless Suture Anchor |
| 10855152006021 - RoG Single | 2018-07-06 2.9mm Suture Anchor with 2x 36" UHMWPE #2 suture |