Boston Scientific

GUDID 15060441917628

Neutral Electrode

NISSHA MEDICAL TECHNOLOGIES LTD

Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use Electrosurgical return electrode, single-use

• Primary Device ID: 15060441917628
• NIH Device Record Key: d4295317-522f-4a0b-bcff-a6276f8a5b62
• Commercial Distribution Discontinuation: 2022-06-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Boston Scientific
• Version Model Number: DGP-PM2-25
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060441917628 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-29
• Device Publish Date: 2021-03-17

On-Brand Devices [Boston Scientific]

• 35060441917646: Neutral Electrode
• 15060441917635: Neutral Electrode
• 35060441917622: Neutral Electrode
• 35060441917615: Neutral Electrode
• 15060441917642: Neutral Electrode
• 15060441917628: Neutral Electrode