ELRA Electrode

GUDID 08809922260699

STARMED CO.,LTD

Endoscopic electrosurgical electrode, bipolar, single-use

• Primary Device ID: 08809922260699
• NIH Device Record Key: 1a4d7e07-a11e-4b28-b9a1-ab07ca184754
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELRA Electrode
• Version Model Number: 7-4B33L
• Company DUNS: 694699723
• Company Name: STARMED CO.,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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809922260699 [Primary]
GS1	18809922260696 [Package]; Package: Carton [5 Units]; In Commercial Distribution
GS1	28809922260693 [Package]; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233113

FDA Product Code

• KNS: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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: 2023-12-04
• Device Publish Date: 2023-11-24

On-Brand Devices [ELRA Electrode]

• 28809306762416: The ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosu
• 18809306762402: The ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosu
• 28809306762393: The ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosu
• 28809306762386: The ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosu
• 28809306762379: The ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosu
• 28809306762362: The ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosu
• 28809306762355: The ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosu
• 28809306762348: The ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosu
• 08809922260699: 7-4B33L
• 08809922260682: 7-4B33S
• 08809922260675: 7-4B18L
• 08809922260668: 7-4B18S
• 08809922260651: 7-2B22L
• 08809922260644: 7-2B22S
• 08809922260620: 7-2B11S
• 18809922260634: 7-2B11L