Stryker 700000856

GUDID 35060842920023

Neutral Electrodes intended to be used in combination with the device “Stryker MultiGen 2 RF Generator”

NISSHA MEDICAL TECHNOLOGIES LTD

Electrosurgical return electrode, single-use

• Primary Device ID: 35060842920023
• NIH Device Record Key: 3922d9b4-db1b-482f-b43d-5f54892a956d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stryker
• Version Model Number: 0406-650-205
• Catalog Number: 700000856
• Company DUNS: 671405566
• Company Name: NISSHA MEDICAL TECHNOLOGIES LTD
• Device Count: 5
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060842920022 [Unit of Use]
GS1	15060842920029 [Primary]
GS1	35060842920023 [Package]; Contains: 15060842920029; Package: PE Bag [25 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: 2022-08-25
• Device Publish Date: 2022-08-17

Devices Manufactured by NISSHA MEDICAL TECHNOLOGIES LTD

• 35060842920146 - Dräger: 2024-03-11 ECG Electrode
• 35060842920153 - Dräger: 2024-03-11 ECG Electrode
• 35060842920023 - Stryker: 2022-08-25Neutral Electrodes intended to be used in combination with the device “Stryker MultiGen 2 RF Generator”
• 35060842920023 - Stryker: 2022-08-25 Neutral Electrodes intended to be used in combination with the device “Stryker MultiGen 2 RF Generator”
• 15060441917628 - Boston Scientific: 2022-06-29 Neutral Electrode
• 15060441917642 - Boston Scientific: 2022-06-29 Neutral Electrode
• 35060441919992 - Maestro: 2022-02-04 Neutral Electrode
• 35060441919244 - Swaroplate: 2021-05-07 Neutral Electrode
• 35060441919251 - Swaroplate: 2021-05-07 Neutral Electrode