| Primary Device ID | 00841494107000 |
| NIH Device Record Key | 4b243807-482a-41ba-a85d-119619866947 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dental Elec. Set |
| Version Model Number | DDS35 |
| Catalog Number | DDS35 |
| Company DUNS | 079095245 |
| Company Name | Ellman International |
| Device Count | 35 |
| 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 | true |
| 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 | 00841494107000 [Primary] |
| GS1 | 00841494107451 [Unit of Use] |
| JOS | Electrode, electrosurgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2017-01-30 |
| 00841494102371 - CORNEAL SHIELD | 2019-05-23 CORNEAL SHIELD L(BLUE), 4 SHIELD, 1 HDLE |
| 00841494102388 - CORNEAL SHIELD | 2019-05-23 CORNEAL SHIELD M(GREEN),4 SHIELD,1 HDLE |
| 00841494102395 - CORNEAL SHIELD | 2019-05-23 CORNEAL SHIELD S(RED),4 SHIELDS,1 HANDLE |
| 00841494102401 - CORNEAL SHIELDS | 2019-05-23 CORNEAL SHIELDS ASSORTED PACKAGE(S, M, L) |
| 00841494104801 - SUCTION HANDLE | 2019-05-23 SUCTION HANDLE(25PCS)FOR CORNEAL SHIELDS |
| 00841494104818 - SUCTION HANDLE FOR CORNEAL SHIELDS | 2019-05-23 SUCTION HANDLE(2PCS) FOR CORNEAL SHIELDS |
| 00841494101015 - 1/8" PIN ELECTRODE | 2019-02-07 1/8" PIN ELECTRODE - 25 PCS STERILE |
| 00841494101305 - Needle Electrode | 2019-02-07 3/4" STRAIGHT NEEDLE STERILE, SINGLE-USE |