OTN TEARAWAY

GUDID 50884908028831

OTN FOR 3F PICC

Medical Components, Inc.

Vascular dilator, single-use

• Primary Device ID: 50884908028831
• NIH Device Record Key: 07759675-bd3e-494f-a3dc-3b06bc7dccb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTN TEARAWAY
• Version Model Number: MC2213
• 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	00884908028836 [Primary]
GS1	50884908028831 [Package]; Contains: 00884908028836; Package: box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K920907

FDA Product Code

• DYB: INTRODUCER, 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: 2016-04-07

On-Brand Devices [OTN TEARAWAY]

• 50884908092115: OTN FOR 2.6F PICC
• 50884908085483: OTN FOR 1.9F PICC
• 50884908028848: OTN FOR 4F PICC
• 50884908028831: OTN FOR 3F PICC