Inno Hydrowire

GUDID 06971564430395

Suzhou Innomed Medical Device . Co., Ltd.

Peripheral vascular guidewire, manual

• Primary Device ID: 06971564430395
• NIH Device Record Key: c181ad9c-4486-4d0b-ab29-d8edbfe57e75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inno Hydrowire
• Version Model Number: SW-35-180-A-3-H
• Company DUNS: 560446555
• Company Name: Suzhou Innomed Medical Device . 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971564430395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172187

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: 2020-07-23
• Device Publish Date: 2020-07-15

On-Brand Devices [Inno Hydrowire]

• 16971564430156: SW-35-260-A-3-H
• 16971564430118: SW-35-150-A-3-D
• 06971564430395: SW-35-180-A-3-H