Inno-Pathwire

GUDID 16971564430217

Suzhou Innomed Medical Device . Co., Ltd.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 16971564430217
• NIH Device Record Key: 4e030388-3dcb-4fc9-9aa6-b218b03a6e05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inno-Pathwire
• Version Model Number: IW-14-190-STS
• 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	06971564430210 [Primary]
GS1	16971564430217 [Package]; Contains: 06971564430210; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182553

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: 2019-09-30
• Device Publish Date: 2019-09-20

On-Brand Devices [Inno-Pathwire]

• 16971564430217: IW-14-190-STS
• 16971564430200: IW-14-190-EXS
• 06971564432382: IW-14-300-MDS