Bipolar Cable SIEC-JX/B

GUDID 00810026180507

IEC Bipolar Cord, Reusable

SONIQUENCE, LLC

Electrical-only medical device connection cable, reusable

• Primary Device ID: 00810026180507
• NIH Device Record Key: fdfe47ef-524c-48ac-8a5a-fdcec7212222
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bipolar Cable
• Version Model Number: SIEC-JX/B
• Catalog Number: SIEC-JX/B
• Company DUNS: 117308190
• Company Name: SONIQUENCE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810026180507 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211946

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[00810026180507]

Moist Heat or Steam Sterilization

[00810026180507]

Moist Heat or Steam Sterilization

[00810026180507]

Moist Heat or Steam Sterilization

[00810026180507]

Moist Heat or Steam Sterilization

[00810026180507]

Moist Heat or Steam Sterilization

[00810026180507]

Moist Heat or Steam Sterilization

[00810026180507]

Moist Heat or Steam Sterilization

[00810026180507]

Moist Heat or Steam Sterilization

[00810026180507]

Moist Heat or Steam Sterilization

[00810026180507]

Moist Heat or Steam Sterilization

[00810026180507]

Moist Heat or Steam Sterilization

[00810026180507]

Moist Heat or Steam Sterilization

[00810026180507]

Moist Heat or Steam Sterilization

[00810026180507]

Moist Heat or Steam Sterilization

[00810026180507]

Moist Heat or Steam Sterilization

[00810026180507]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-27
• Device Publish Date: 2021-09-19

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• 00810026181740: Bipolar Cable, European, Sterile/Disposable (1 pc)
• 00810026181528: Flat Prong Plug Bipolar Cable, Sterile/Disposable
• 00810026181511: Bipolar Cable, Sterile/Disposable
• 00810026180521: Bipolar Scissor Cable, Reusable
• 00810026180514: IEC Universal Bipolar Cable, Reusable
• 00810026180507: IEC Bipolar Cord, Reusable