| Primary Device ID | 00815137020421 |
| NIH Device Record Key | 80ed354f-935b-4325-9dea-176b1b9f9080 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | S-SPOT |
| Version Model Number | 677 |
| Company DUNS | 001157841 |
| Company Name | Beekley Corporation |
| Device Count | 280 |
| 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 | 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 | 00815137020421 [Primary] |
| GS1 | 10815137020428 [Unit of Use] |
| JAC | System, X-Ray, Film Marking, Radiographic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-30 |
| Device Publish Date | 2019-07-22 |
| 00815137021862 | Scar Markers, 1mm diameter uniform ultra-sheer see-through line, pinch free material |
| 00815137021817 | Scar Markers, 1mm diameter uniform low-density see-through line, pinch free material |
| 00815137021763 | Scar Markers, 1mm diameter uniform low-density see-through line |
| 00815137021718 | Scar Markers, .33mm diameter radiopaque line |
| 00815137020476 | Scar Markers, 1mm diameter uniform ultra-sheer see-through line, pinch free material |
| 00815137020421 | Scar Markers, 1mm diameter uniform low-density see-through line, pinch free material |
| 00815137020377 | Scar Markers, 1mm diameter uniform low-density see-through line |
| 00815137020322 | Scar Markers, .33mm diameter radiopaque line |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() S-SPOT 86346077 4695699 Live/Registered |
Beekley Corporation 2014-07-23 |