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 |