| Primary Device ID | 00853512006783 |
| NIH Device Record Key | 0696ff44-3b3f-4867-8540-71f6baf3b252 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | USB Medical HV Atrial Heart Retractor - Complete Set |
| Version Model Number | HV-2001 |
| Catalog Number | HV-2001 |
| Company DUNS | 073648341 |
| Company Name | NIKOMED USA |
| Device Count | 1 |
| 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com | |
| Phone | +1(800)355-6456 |
| info@nikomedusa.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853512006783 [Primary] |
| DWS | Instruments, Surgical, Cardiovascular |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00853512006783]
Moist Heat or Steam Sterilization
[00853512006783]
Moist Heat or Steam Sterilization
[00853512006783]
Moist Heat or Steam Sterilization
[00853512006783]
Moist Heat or Steam Sterilization
[00853512006783]
Moist Heat or Steam Sterilization
[00853512006783]
Moist Heat or Steam Sterilization
[00853512006783]
Moist Heat or Steam Sterilization
[00853512006783]
Moist Heat or Steam Sterilization
[00853512006783]
Moist Heat or Steam Sterilization
[00853512006783]
Moist Heat or Steam Sterilization
[00853512006783]
Moist Heat or Steam Sterilization
[00853512006783]
Moist Heat or Steam Sterilization
[00853512006783]
Moist Heat or Steam Sterilization
[00853512006783]
Moist Heat or Steam Sterilization
[00853512006783]
Moist Heat or Steam Sterilization
[00853512006783]
Moist Heat or Steam Sterilization
[00853512006783]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-21 |
| Device Publish Date | 2023-03-13 |
| 20853512006954 - NIKOTRACE | 2025-08-18 ECG Electrodes |
| 20853512006961 - NIKOTRACE | 2025-08-18 Repositionable ECG Electrodes |
| 30853512006517 - NikoSurg | 2025-06-18 Neutral Electrodes |
| 20853512006572 - NikoSurg | 2025-06-18 Neutral Electrodes |
| 20853512006817 - NIKOTRACE | 2025-03-31 ECG Electrodes |
| 00853512006820 - NIKOTRACE | 2025-03-31 ECG Electrodes |
| 20853512006831 - NIKOTRACE | 2025-03-31 ECG Electrodes |
| 20853512006848 - NIKOTRACE | 2025-03-31 ECG Electrodes |