Transfermoral Transcaval Liver Biopsy System TF-18C

GUDID 20886333227659

Transfermoral Transcaval Liver Biopsy System

ARGON MEDICAL DEVICES, INC.

End-cut biopsy gun handpiece/needle

• Primary Device ID: 20886333227659
• NIH Device Record Key: f43cfd9e-642a-42b5-a756-2a3c0d27550a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transfermoral Transcaval Liver Biopsy System
• Version Model Number: TF-18C
• Catalog Number: TF-18C
• 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

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	00886333227655 [Primary]
GS1	20886333227659 [Package]; Contains: 00886333227655; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241145

FDA Product Code

• DYB: Introducer, Catheter

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: 2024-08-20
• Device Publish Date: 2024-08-12

Devices Manufactured by ARGON MEDICAL DEVICES, INC.

• 20886333227659 - Transfermoral Transcaval Liver Biopsy System: 2024-08-20Transfermoral Transcaval Liver Biopsy System
• 20886333227659 - Transfermoral Transcaval Liver Biopsy System: 2024-08-20 Transfermoral Transcaval Liver Biopsy System
• 20886333227499 - ClosureFast Guidewire: 2024-08-06 ClosureFast™ Guidewire J Tip, PTFE, Fixed Core, 0.025" (0.64mm) x 260cm
• 20886333227505 - ClosureFast Guidewire: 2024-08-06 ClosureFast™ Guidewire Double Ended, PTFE, Fixed Core 0.035" (0.89mm) x 45cm
• 20886333227512 - ClosureFast Introducer Sheath: 2024-08-06 ClosureFast Introducer Sheath Set 7Fr/Ch (2.3mm) x 7cm
• 20886333227529 - ClosureFast Introducer Sheath: 2024-08-06 ClosureFast™ Introducer Sheath Set 7Fr/Ch (2.3mm) x 11cm
• 20886333227550 - ClosureFast Micro Puncture: 2024-08-06 ClosureFast™ Micro Puncture Kit 4Fr/Ch (1.3mm)
• 20886333227567 - ClosureFast Micro Puncture: 2024-08-06 ClosureFast™ Micro Puncture Kit 5Fr/Ch (1.7mm)
• 20886333227574 - ClosureFast Tumescent Infiltration Kit: 2024-08-06 ClosureFast™ Tumescent Infiltration Kit