GALT MEDICAL GUIDEWIREGALT MEDICAL GUIDEWIRE

GUDID 50884908105259

0.010 (0.26MM) X 20CM0.010 (0.26 NITINOL GUIDEWIRENITINOL GUIDEWI

Medical Components, Inc.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 50884908105259
• NIH Device Record Key: 1fdd3a30-e549-4914-89a2-9a747a46252f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GALT MEDICAL GUIDEWIREGALT MEDICAL GUIDEWIRE
• Version Model Number: MR190020
• Company DUNS: 038000253
• Company Name: Medical Components, Inc.
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(215)256-4201
• Email: clinical@medcompnet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884908105254 [Primary]
GS1	50884908105259 [Package]; Contains: 00884908105254; Package: box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021990

FDA Product Code

• DQX: Wire, guide, catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-28

On-Brand Devices [GALT MEDICAL GUIDEWIREGALT MEDICAL GUIDEWIRE]

• 30884908105279: 0.010" (0.26MM) X 40CM0.010" (0. NITINOL GUIDEWIRENITINOL GUIDEWI
• 50884908105259: 0.010 (0.26MM) X 20CM0.010 (0.26 NITINOL GUIDEWIRENITINOL GUIDEWI
• 30884908016902: 0.018" (0.46MM) X 130CM NITINOL GUIDEWIRE W/ RADIOPAQUE TIP