TMW

GUDID 00816840020395

HERAEUS MEDICAL COMPONENTS, LLC

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 00816840020395
• NIH Device Record Key: f5aa0e36-a1dc-4b97-8681-ee3e8ea8d0d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TMW
• Version Model Number: SP-4091-106
• Company DUNS: 080645456
• Company Name: HERAEUS MEDICAL COMPONENTS, LLC
• 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	00816840020395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173052

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: 2018-09-03
• Device Publish Date: 2018-08-01

On-Brand Devices [TMW]

• 00816840020401: SP-4091-107
• 00816840020395: SP-4091-106
• 00816840020388: SP-4091-105
• 00816840020371: SP-4091-104