Swaroplate 6000847N

GUDID 35060441919626

Neutral Electrode

NISSHA MEDICAL TECHNOLOGIES LTD

Electrosurgical return electrode, single-use

• Primary Device ID: 35060441919626
• NIH Device Record Key: a442651b-6b2f-4e7e-b6dc-47832d3868be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Swaroplate
• Version Model Number: 1288H
• Catalog Number: 6000847N
• Company DUNS: 671405566
• Company Name: NISSHA MEDICAL TECHNOLOGIES LTD
• 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: true
• 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060441919622 [Primary]
GS1	35060441919626 [Package]; Contains: 15060441919622; Package: Box [8 Units]; In Commercial Distribution
GS1	55060441919620 [Package]; Package: Case [96 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203494

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-06
• Device Publish Date: 2021-04-28

On-Brand Devices [Swaroplate]

• 35060441919237: Neutral Electrode
• 35060441919220: Neutral Electrode
• 35060441919213: Neutral Electrode
• 35060441919206: Neutral Electrode
• 35060441919190: Neutral Electrode
• 35060441919626: Neutral Electrode
• 35060441919619: Neutral Electrode
• 35060441919602: Neutral Electrode
• 35060441919596: Neutral Electrode
• 35060441919589: Neutral Electrode
• 35060441919572: Neutral Electrode
• 35060441919565: Neutral Electrode
• 35060441919558: Neutral Electrode
• 35060441919541: Neutral Electrode
• 35060441919534: Neutral Electrode
• 35060441919527: Neutral Electrode
• 35060441919510: Neutral Electrode
• 35060441919503: Neutral Electrode
• 35060441919497: Neutral Electrode
• 35060441919480: Neutral Electrode
• 35060441919473: Neutral Electrode
• 35060441919466: Neutral Electrode
• 35060441919459: Neutral Electrode
• 35060441919442: Neutral Electrode
• 35060441919435: Neutral Electrode
• 35060441919428: Neutral Electrode
• 35060441919411: Neutral Electrode
• 35060441919404: Neutral Electrode
• 35060441919398: Neutral Electrode
• 35060441919381: Neutral Electrode
• 35060441919374: Neutral Electrode
• 35060441919367: Neutral Electrode
• 35060441919350: Neutral Electrode
• 35060441919343: Neutral Electrode
• 35060441919336: Neutral Electrode
• 35060441919329: Neutral Electrode
• 35060441919312: Neutral Electrode
• 35060441919305: Neutral Electrode
• 35060441919299: Neutral Electrode
• 35060441919282: Neutral Electrode
• 35060441919275: Neutral Electrode
• 35060441919268: Neutral Electrode
• 35060441919251: Neutral Electrode
• 35060441919244: Neutral Electrode