PROEMG

GUDID 18809083944534

Concentric Needle, Non-Wired, 30mm(L)x0.36mm(D), Blue Hub

BIOPROTECH INC.

Electromyographic needle electrode, single-use

• 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

Operating and Storage Conditions

• 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 Identifiers

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

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152984

FDA Product Code

• GXZ: Electrode, Needle

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-07
• Device Publish Date: 2024-12-30

On-Brand Devices [PROEMG]

• 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