| Primary Device ID | 30009336010227 |
| NIH Device Record Key | 717578c6-fbdd-442e-ae43-0519b2e8066e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DuraTENS |
| Version Model Number | 700000548 |
| Catalog Number | 700000548 |
| Company DUNS | 002111896 |
| Company Name | GRAPHIC CONTROLS ACQUISITION CORP |
| Device Count | 4 |
| 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 | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 800-853-7500 |
| HS.Info@NisshaMedical.com | |
| Phone | 800-853-7500 |
| HS.Info@NisshaMedical.com | |
| Phone | 800-853-7500 |
| HS.Info@NisshaMedical.com | |
| Phone | 800-853-7500 |
| HS.Info@NisshaMedical.com | |
| Phone | 800-853-7500 |
| HS.Info@NisshaMedical.com | |
| Phone | 800-853-7500 |
| HS.Info@NisshaMedical.com | |
| Phone | 800-853-7500 |
| HS.Info@NisshaMedical.com | |
| Phone | 800-853-7500 |
| HS.Info@NisshaMedical.com | |
| Phone | 800-853-7500 |
| HS.Info@NisshaMedical.com | |
| Phone | 800-853-7500 |
| HS.Info@NisshaMedical.com | |
| Phone | 800-853-7500 |
| HS.Info@NisshaMedical.com | |
| Phone | 800-853-7500 |
| HS.Info@NisshaMedical.com | |
| Phone | 800-853-7500 |
| HS.Info@NisshaMedical.com | |
| Phone | 800-853-7500 |
| HS.Info@NisshaMedical.com | |
| Phone | 800-853-7500 |
| HS.Info@NisshaMedical.com | |
| Phone | 800-853-7500 |
| HS.Info@NisshaMedical.com | |
| Phone | 800-853-7500 |
| HS.Info@NisshaMedical.com | |
| Phone | 800-853-7500 |
| HS.Info@NisshaMedical.com | |
| Phone | 800-853-7500 |
| HS.Info@NisshaMedical.com | |
| Phone | 800-853-7500 |
| HS.Info@NisshaMedical.com | |
| Phone | 800-853-7500 |
| HS.Info@NisshaMedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00009336010226 [Unit of Use] |
| GS1 | 10009336010223 [Primary] |
| GS1 | 30009336010227 [Package] Contains: 10009336010223 Package: Box [60 Units] In Commercial Distribution |
| GS1 | 50009336010221 [Package] Contains: 10009336010223 Package: Case/Master Carton [1800 Units] In Commercial Distribution |
| GXY | Electrode, Cutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-19 |
| Device Publish Date | 2022-04-11 |
| 30009336010227 | Ref SS-3 Supplier PN: R50100C2WF-T Neurostimulation Electrode |
| 30009336010210 | Ref SS-2 Supplier PN: S5050C2WF-T Neurostimulation Electrode |