| Primary Device ID | 00382830017572 |
| NIH Device Record Key | 98146038-8a85-494e-b80d-2e784d91bab4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Teca Elite |
| Version Model Number | 902-DMG50-S |
| Company DUNS | 896421240 |
| Company Name | NATUS MANUFACTURING LIMITED |
| Device Count | 1 |
| 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 | 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 | 00382830017572 [Primary] |
| IKT | Electrode, Needle, Diagnostic Electromyograph |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-06-11 |
| Device Publish Date | 2016-08-25 |
| 00382830017589 | TECA Elite Disposable Monopolar Violet Needle, 75mmx26G (24) per PK |
| 00382830017572 | TECA Elite Disposable Monopolar Blue Needle, 50mmx26G (48) per PK |
| 00382830017565 | TECA Elite Disposable Monopolar Green Needle, 37mmx26G (48) per PK |
| 00382830017558 | TECA Elite Disposable Monopolar Yellow Needle, 25mmx26G (48) per PK |
| 00382830017541 | TECA Elite Disposable Monopolar Orange Needle, 37mmx28G (48) per PK |
| 00382830017534 | TECA Elite Disposable Monopolar Red Needle, 25mmx28G (48) per PK |
| 00382830017527 | TECA ELITE Disposable Concentric Violet Needle, 75mm, .64(23G) diameter, 25 per Pk |
| 00382830017510 | TECA ELITE Disposable Concentric Blue Needle, 50mm, .46(26G) diameter, 25 per Pk |
| 00382830017503 | TECA ELITE Disposable Concentric Green Needle, 37mm,.46(26G) diameter, 25 per Pk |
| 00382830017497 | TECA ELITE Disposable Concentric Yellow Needle, 25mm, .46(26G) diameter, 25 per Pk |
| 00382830017480 | TECA ELITE Disposable Concentric Red Needle, 25mm, .3(30G) diameter, 25 per Pk |