Single-use Guidewire

GUDID 16971381251637

The guide wire is an introducer, which uses the maneuverability and support characteristics of the guide wire to guide the catheter or other instrument into the cavity.

SCIVITA MEDICAL TECHNOLOGY CO., LTD.

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• Primary Device ID: 16971381251637
• NIH Device Record Key: 0b897bc6-6326-4fb8-bfb8-af1582839747
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single-use Guidewire
• Version Model Number: GW-3515
• Company DUNS: 544519831
• Company Name: SCIVITA MEDICAL TECHNOLOGY CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971381251630 [Primary]
GS1	16971381251637 [Package]; Contains: 06971381251630; Package: [5 Units]; In Commercial Distribution
GS1	26971381251634 [Package]; Package: [180 Units]; In Commercial Distribution

FDA Product Code

• OCY: Endoscopic Guidewire, Gastroenterology-Urology

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: 2023-06-01
• Device Publish Date: 2023-05-24

Devices Manufactured by SCIVITA MEDICAL TECHNOLOGY CO., LTD.

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• 16971381253174 - Single-use Biopsy Forceps: 2024-01-05 This product is intended to collect tissue samples endoscopically for histologic examination.
• 16971381253181 - Single-use Biopsy Forceps: 2024-01-05 This product is intended to collect tissue samples endoscopically for histologic examination.
• 16971381253198 - Single-use Biopsy Forceps: 2024-01-05 This product is intended to collect tissue samples endoscopically for histologic examination.