Percutaneous Entry Needle 195326

GUDID 10886333208460

Percutaneous Entry Needle - 18ga x 2 7/8” (7.3cm)

ARGON MEDICAL DEVICES, INC.

Vascular catheter introduction needle Vascular catheter introduction needle

• Primary Device ID: 10886333208460
• NIH Device Record Key: 915d5b21-94b7-4a23-b99c-3cd9cf26b060
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Percutaneous Entry Needle
• Version Model Number: 195326
• Catalog Number: 195326
• Company DUNS: 140727624
• Company Name: ARGON MEDICAL DEVICES, 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886333208463 [Primary]
GS1	10886333208460 [Package]; Contains: 00886333208463; Package: Box [10 Units]; In Commercial Distribution
GS1	20886333208467 [Package]; Contains: 00886333208463; Package: Box [150 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K772369

FDA Product Code

• DRC: Trocar

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: 2016-09-10

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