| Primary Device ID | 18809083944534 |
| NIH Device Record Key | fbd13058-6d01-4ada-b213-2d053c3e85b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PROEMG |
| Version Model Number | BC3028 |
| Company DUNS | 688460539 |
| Company Name | BIOPROTECH INC. |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809083944537 [Primary] |
| GS1 | 18809083944534 [Package] Contains: 08809083944537 Package: Inner Box [25 Units] In Commercial Distribution |
| GS1 | 28809083944531 [Package] Package: Carton Box [8 Units] In Commercial Distribution |
| GXZ | Electrode, Needle |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-07 |
| Device Publish Date | 2024-12-30 |
| 18809083944626 | Monopolar Needle, Non-Wired, 75mmx0.45mm(D), Red Hub |
| 18809083944619 | Monopolar Needle, Non-Wired, 37mmx0.45mm(D), Green Hub |
| 18809083944602 | Monopolar Needle, Non-Wired, 25mm(L)x0.45mm(D), Gray Hub |
| 18809083944596 | Monopolar Needle, Prewired, 75mmx0.45mm(D), Red Hub |
| 18809083944589 | Monopolar Needle, Prewired, 25mmx0.45mm(D), Gray Hub |
| 18809083944572 | Monopolar Needle, Prewired, 37mmx0.45mm(D), Green Hub |
| 18809083944565 | Concentric Needle, Non-Wired, 75mm(L)x0.65mm(D), Red Hub |
| 18809083944558 | Concentric Needle, Non-Wired, 50mm(L)x0.45mm(D), Yellow Hub |
| 18809083944541 | Concentric Needle, Non-Wired, 38mm(L)x0.45mm(D), Green Hub |
| 18809083944534 | Concentric Needle, Non-Wired, 30mm(L)x0.36mm(D), Blue Hub |
| 18809083944527 | Concentric Needle, Non-Wired, 25mm(L)x0.30mm(D), White Hub |
| 18809083944510 | Concentric Needle, Non-Wired, 25mm(L)x0.45mm(D), Gray Hub |
| 18809083943469 | Monopolar Needle, Prewired, 50mmx0.45mm(D), Yellow Hub |
| 18809083943452 | Monopolar Needle, Prewired, 37mmx0.36mm(D), Blue Hub |
| 18809083943445 | Monopolar Needle, Non-Wired, 50mmx0.45mm(D), Yellow Hub |
| 18809083943438 | Monopolar Needle, Non-Wired, 37mmx0.36mm(D), Blue Hub |
| 18809083943421 | Monopolar Needle, Prewired, 25mmx0.36mm(D), White Hub |
| 18809083943414 | Monopolar Needle, Non-Wired, 25mmx0.36mm(D), White Hub |