GALT GUIDEWIREGALT GUIDEWIRE DMR190040

GUDID 30884908145091

0.010" (0.26MM) X 40CM0.010" (0. NITINOL GUIDEWIRENITINOL GUIDEWI

Medical Components, Inc.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 30884908145091
• NIH Device Record Key: 548b95c1-ace7-48ee-974d-ff081ff4a609
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GALT GUIDEWIREGALT GUIDEWIRE
• Version Model Number: DMR190040
• Catalog Number: DMR190040
• 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	00884908145090 [Primary]
GS1	30884908145091 [Package]; Contains: 00884908145090; Package: inner box [10 Units]; In Commercial Distribution
GS1	50884908145095 [Package]; Package: box [4 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-12
• Device Publish Date: 2019-09-04

Devices Manufactured by Medical Components, Inc.

• 50884908182564 - SPLIT CATH® III: 2025-04-04 VASCULAR ACCESS TRAY WITH 16F X 24CM Split Cath® (CUFF 19CM FROM TIP)
• 50884908181864 - SPLIT-CATH® III: 2025-04-03 14F X 24CM SPLIT CATH® III CATHETER SET (CUFF 19CM FROM TIP)
• 50884908181871 - SPLIT CATH® III: 2025-04-03 16F X 24CM SPLIT CATH® III CATHETER SET (CUFF 19CM FROM TIP)
• 50884908181888 - SPLIT-CATH® III: 2025-04-03 14F X 28CM SPLIT CATH® III CATHETER SET (CUFF 23CM FROM TIP)
• 50884908181895 - SPLIT CATH® III: 2025-04-03 16F X 28CM SPLIT CATH® III CATHETER SET (CUFF 23CM FROM TIP)
• 50884908181901 - SPLIT-CATH® III: 2025-04-03 14F X 32CM SPLIT CATH® III CATHETER SET (CUFF 27CM FROM TIP)
• 50884908181918 - SPLIT CATH® III: 2025-04-03 16F X 32CM SPLIT CATH® III CATHETER SET (CUFF 27CM FROM TIP)
• 50884908181925 - SPLIT CATH® III: 2025-04-03 14F X 36CM SPLIT CATH® III CATHETER SET (CUFF 31CM FROM TIP)