Screw Dilator 631038025

GUDID 20886333004939

Screw Dilator 10F x 25cm

ARGON MEDICAL DEVICES, INC.

Fascial tissue dilator, single-use

• Primary Device ID: 20886333004939
• NIH Device Record Key: c574987e-9ee2-4308-bc36-4c319a60b97d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Screw Dilator
• Version Model Number: 631038025
• Catalog Number: 631038025
• 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
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886333004935 [Primary]
GS1	20886333004939 [Package]; Contains: 00886333004935; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990808

FDA Product Code

• GCC: Dilator, 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: 2016-09-12

On-Brand Devices [Screw Dilator]

• 20886333004960: Screw Dilator 16F x 25cm
• 20886333004953: Screw Dilator 14F x 25cm
• 20886333004946: Screw Dilator 12F x 25cm
• 20886333004939: Screw Dilator 10F x 25cm
• 20886333004922: Screw Dilator 9F x 25cm
• 20886333004915: Screw Dilator 8F x 25cm
• 20886333004908: Screw Dilator 7Fr x 25cm