MANAN GWI GUIDE WIRE INTRODUCERMANAN GWI GUIDE WIRE INTRODUCER

GUDID 50884908105280

22GA X 1.5" (3.8CM)22GA X 1.5" ( INTRODUCER NEEDLEINTRODUCER NEED

Medical Components, Inc.

Vascular catheter introduction needle

• Primary Device ID: 50884908105280
• NIH Device Record Key: 00839ad7-8d4e-4539-a05f-04826c08b9f4
• Commercial Distribution Discontinuation: 2018-11-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MANAN GWI GUIDE WIRE INTRODUCERMANAN GWI GUIDE WIRE INTRODUCER
• Version Model Number: MC224
• 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	00884908105285 [Primary]
GS1	50884908105280 [Package]; Contains: 00884908105285; Package: box [1 Units]; Discontinued: 2018-11-14; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K851834

FDA Product Code

• DWS: INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-16
• Device Publish Date: 2018-01-13

On-Brand Devices [MANAN GWI GUIDE WIRE INTRODUCERMANAN GWI GUIDE WIRE INTRODUCER]

• 50884908105280: 22GA X 1.5" (3.8CM)22GA X 1.5" ( INTRODUCER NEEDLEINTRODUCER NEED
• 50884908029685: 18GA X 7CM ONE-PART18GA X 7CM ON COURNAND NEEDLECOURNAND NEEDLE
• 50884908028817: 21GA X 7CM CLEAR HUB NEEDLE21GA
• 50884908028787: 21GA X 4CM ECHO TIP21GA X 4CM EC NEEDLENEEDLE