ELRA Electrode

GUDID 28809306762355

The ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators. The ELRA Electrode consists of an electrode tip, insulation part, handle. Patient contacting materials of ELRA Electrode are stainless steel 304, Teflon-ETFE, UV adhesive, Nylon, PEEK and polyether block amides.

STARMED CO.,LTD

Endoscopic electrosurgical electrode, bipolar, single-use

• Primary Device ID: 28809306762355
• NIH Device Record Key: 592284f9-8eff-472f-9a99-1e3fa3fdbf1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELRA Electrode
• Version Model Number: 7-2B11L
• 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

Customer Support Contacts

• Phone: +82318163546
• Email: inquiry@starmed4u.com

Device Dimensions

• Shaft Length: 175 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809306762351 [Primary]
GS1	18809306762358 [Package]; Contains: 08809306762351; Package: Carton [5 Units]; In Commercial Distribution
GS1	28809306762355 [Package]; Contains: 08809306762351; Package: Carton [10 Units]; In Commercial Distribution

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: 2019-04-29
• Device Publish Date: 2019-04-19

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