TalWire

GUDID 17290019773037

EMBRACE MEDICAL LTD

Peripheral vascular guidewire, manual

• Primary Device ID: 17290019773037
• NIH Device Record Key: 9f309793-348b-4198-8329-01300adcc2c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TalWire
• Version Model Number: SP-4003-008
• Company DUNS: 532377560
• Company Name: EMBRACE MEDICAL 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 Dimensions

• Guidewire Diameter: 0.021 Inch
• Guidewire Length: 80 Centimeter
• Guidewire Diameter: 0.021 Inch
• Guidewire Length: 80 Centimeter
• Guidewire Diameter: 0.021 Inch
• Guidewire Length: 80 Centimeter
• Guidewire Diameter: 0.021 Inch
• Guidewire Length: 80 Centimeter
• Guidewire Diameter: 0.021 Inch
• Guidewire Length: 80 Centimeter
• Guidewire Diameter: 0.021 Inch
• Guidewire Length: 80 Centimeter
• Guidewire Diameter: 0.021 Inch
• Guidewire Length: 80 Centimeter
• Guidewire Diameter: 0.021 Inch
• Guidewire Length: 80 Centimeter
• Guidewire Diameter: 0.021 Inch
• Guidewire Length: 80 Centimeter
• Guidewire Diameter: 0.021 Inch
• Guidewire Length: 80 Centimeter
• Guidewire Diameter: 0.021 Inch
• Guidewire Length: 80 Centimeter
• Guidewire Diameter: 0.021 Inch
• Guidewire Length: 80 Centimeter
• Guidewire Diameter: 0.021 Inch
• Guidewire Length: 80 Centimeter
• Guidewire Diameter: 0.021 Inch
• Guidewire Length: 80 Centimeter
• Guidewire Diameter: 0.021 Inch
• Guidewire Length: 80 Centimeter
• Guidewire Diameter: 0.021 Inch
• Guidewire Length: 80 Centimeter
• Guidewire Diameter: 0.021 Inch
• Guidewire Length: 80 Centimeter
• Guidewire Diameter: 0.021 Inch
• Guidewire Length: 80 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019773030 [Primary]
GS1	17290019773037 [Package]; Contains: 07290019773030; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223791

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: 2023-08-10
• Device Publish Date: 2023-08-02

On-Brand Devices [TalWire]

• 17290019773037: SP-4003-008
• 17290019773020: SP-4003-006
• 17290019773013: SP-4003-004
• 07290019773009: SP-4003-002