ClosureFast Introducer Sheath IS-7F11

GUDID 20886333227529

ClosureFast™ Introducer Sheath Set 7Fr/Ch (2.3mm) x 11cm

ARGON MEDICAL DEVICES, INC.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 20886333227529
• NIH Device Record Key: efe9f290-b293-4fb2-8aad-33bb9a0ae1b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClosureFast Introducer Sheath
• Version Model Number: IS-7F11
• Catalog Number: IS-7F11
• 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
• 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 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886333227525 [Primary]
GS1	20886333227529 [Package]; Contains: 00886333227525; Package: Box [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K780126

FDA Product Code

• DRE: Dilator, Vessel, For Percutaneous Catheterization

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: 2024-08-06
• Device Publish Date: 2024-07-29

On-Brand Devices [ClosureFast Introducer Sheath ]

• 20886333227529: ClosureFast™ Introducer Sheath Set 7Fr/Ch (2.3mm) x 11cm
• 20886333227512: ClosureFast Introducer Sheath Set 7Fr/Ch (2.3mm) x 7cm