ITL Essential Standard Quiver A100398

GUDID 19555240400748

Standard quiver, PVC loop, polypropylene, individually packaged and sterile. Device Intended Use: Holder for electrosurgical diathermy system conducting unit and/or other long instruments during surgery. For single use only.

ITL ASIA PACIFIC SDN. BHD.

Electrosurgical handpiece/electrode holder, single-use

• Primary Device ID: 19555240400748
• NIH Device Record Key: 23b3b5c6-6bff-4e08-8788-d9e11e691353
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ITL Essential Standard Quiver
• Version Model Number: A100398
• Catalog Number: A100398
• Company DUNS: 597723837
• Company Name: ITL ASIA PACIFIC SDN. BHD.
• 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: false
• 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: +18884112851
• Email: sales@itlbiomedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	19555240400748 [Package]; Contains: 19555240401141; Package: Carton [30 Units]; In Commercial Distribution
GS1	19555240401141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153472

FDA Product Code

• HAM: Apparatus, Electrosurgical

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: 2019-06-03
• Device Publish Date: 2019-05-25

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