Sunmed Guide Wires

GUDID 06947358535843

Sunny Medical Device (Shenzhen) Co., Ltd.

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 06947358535843
• NIH Device Record Key: e3c310de-ed55-46f4-82d2-febc47d67dd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunmed Guide Wires
• Version Model Number: S tip, 0.035in, 260cm
• Company DUNS: 529639795
• Company Name: Sunny Medical Device (Shenzhen) 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: false
• Expiration Date: true
• 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	06947358535843 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120119

FDA Product Code

• DQX: Wire, Guide, Catheter

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: 2021-12-22
• Device Publish Date: 2021-12-13

On-Brand Devices [Sunmed Guide Wires]

• 06947358535843: S tip, 0.035in, 260cm
• 06947358535812: J tip, 0.035in, 260cm
• 06947358535751: S tip, 0.035in, 150cm
• 06947358535713: J tip, 0.035in, 150cm
• 06947358535508: S tip, 0.035in, 145cm
• 06947358535317: J tip, 0.035in, 175cm