| Primary Device ID | 00841494101152 |
| NIH Device Record Key | 1ce6736f-243e-41d6-945f-e9199d96ebf3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ball Electrode |
| Version Model Number | XD8B |
| Catalog Number | XD8B |
| Company DUNS | 079095245 |
| Company Name | Ellman International |
| Device Count | 5 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | 00841494101152 [Primary] |
| GS1 | 10841494101159 [Unit of Use] |
| JOS | Electrode, electrosurgical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-19 |
| 00841494102760 | ELECTRODE, 3MM BALL 1/16" SHAFT 2PK |
| 00841494102012 | BALL ELECTRODE - 2.3MM - 25PCS STERILE |
| 00841494101756 | 5MM BALL ELECTRODE BENDABLE, 1/16" |
| 00841494101749 | 5MM BALL ELECTRODE 4" L BENDABLE, 1/16" |
| 00841494101633 | 4MM BALL ELECTRODE 4" L BENDABLE, 1/16" |
| 00841494101619 | 4 MM BALL ELECTRODE BENDABLE, 1/16" |
| 00841494101596 | 3MM BALL ELECTRODE BENDABLE, 1/16" |
| 00841494101589 | 3MM BALL ELECTRODE 4" L BENDABLE, 1/16" |
| 00841494101251 | 3.17MM BALL ELECTRODE BENDABLE, 1/16" |
| 00841494101213 | 2MM BALL ELECTRODE BENDABLE, 1/16" |
| 00841494101206 | 2MM BALL ELECTRODE BENDABLE, 1/16" |
| 00841494101190 | 2MM BALL ELECTRODE BENDABLE, 1/16" |
| 00841494101183 | 2MM BALL ELECTRODE 4" L BENDABLE, 1/16" |
| 00841494101176 | 2MM BALL ELECTRODE - 4" BENDABLE, 1/16" |
| 00841494101152 | 2.36MM BALL ELECTRODE BENDABLE, 1/16" |