Total Abscession

GUDID 25051684011683

10F x 40cm Total Abscession Biliary Drainage Catheter (Locking Pigtail)

Angiodynamics, Inc.

Biliary drain

• Primary Device ID: 25051684011683
• NIH Device Record Key: e94c254d-887f-4069-a60a-4740f9b84695
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Total Abscession
• Version Model Number: 14000902
• Company DUNS: 079252781
• Company Name: Angiodynamics, 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: false
• 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)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com

Device Dimensions

• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Catheter Gauge: 10 French
• Length: 40 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051684011686 [Primary]
GS1	25051684011683 [Package]; Contains: 15051684011686; Package: BX [5 Units]; In Commercial Distribution
HIBCC	H787140009020 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170743

FDA Product Code

• FGE: Stents, drains and dilators for the biliary ducts

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: 2024-11-07
• Device Publish Date: 2024-10-30

On-Brand Devices [Total Abscession]

• H787140008105: 14F x 45cm Total Abscession General Drainage Catheter (Locking Pigtail)
• H787140008015: 6.5F x 15cm Total Abscession General Drainage Catheter (Locking Pigtail)
• H787140010095: 14F x 45cm Total Abscession Nephrostomy Drainage Catheter (Locking Pigtail)
• H787140010085: 12F x 45cm Total Abscession Nephrostomy Drainage Catheter (Locking Pigtail)
• H787140010075: 10F x 45cm Total Abscession Nephrostomy Drainage Catheter (Locking Pigtail)
• H787140010065: 8F x 45cm Total Abscession Nephrostomy Drainage Catheter (Locking Pigtail)
• H787140010055: 14F x 30cm Total Abscession Nephrostomy Drainage Catheter (Locking Pigtail)
• H787140010045: 12F x 30cm Total Abscession Nephrostomy Drainage Catheter (Locking Pigtail)
• H787140010035: 10F x 30cm Total Abscession Nephrostomy Drainage Catheter (Locking Pigtail)
• H787140010025: 8F x 30cm Total Abscession Nephrostomy Drainage Catheter (Locking Pigtail)
• H787140010015: 8F x 30cm Total Abscession Nephrostomy Drainage Catheter (Locking Pigtail)
• H787140009045: 14F x 40cm Total Abscession Biliary Drainage Catheter (Locking Pigtail)
• H787140009035: 12F x 40cm Total Abscession Biliary Drainage Catheter (Locking Pigtail)
• H787140009025: 10F x 40cm Total Abscession Biliary Drainage Catheter (Locking Pigtail)
• H787140009015: 8F x 40cm Total Abscession Biliary Drainage Catheter (Locking Pigtail)
• H787140008305: 14F x 45cm Total Abscession General Drainage Catheter (Locking Pigtail)
• H787140008295: 12F x 45cm Total Abscession General Drainage Catheter (Locking Pigtail)
• H787140008285: 10F x 45cm Total Abscession General Drainage Catheter (Locking Pigtail)
• H787140008275: 8F x 45cm Total Abscession General Drainage Catheter (Locking Pigtail)
• H787140008265: 14F x 30cm Total Abscession General Drainage Catheter (Locking Pigtail)
• H787140008255: 12F x 30cm Total Abscession General Drainage Catheter (Locking Pigtail)
• H787140008245: 10F x 30cm Total Abscession General Drainage Catheter (Locking Pigtail)
• H787140008235: 8F x 30cm Total Abscession General Drainage Catheter (Locking Pigtail)
• H787140008095: 12F x 45cm Total Abscession General Drainage Catheter (Locking Pigtail)
• H787140008085: 10F x 45cm Total Abscession General Drainage Catheter (Locking Pigtail)
• H787140008075: 8F x 45cm Total Abscession General Drainage Catheter (Locking Pigtail)
• H787140008065: 14F x 30cm Total Abscession General Drainage Catheter (Locking Pigtail)
• H787140008055: 12F x 30cm Total Abscession General Drainage Catheter (Locking Pigtail)
• H787140008045: 10F x 30cm Total Abscession General Drainage Catheter (Locking Pigtail)
• H787140008035: 8F x 30cm Total Abscession General Drainage Catheter (Locking Pigtail)
• H787140008025: 6.5F x 30cm Total Abscession General Drainage Catheter (Locking Pigtail)
• 25051684011706: 14F x 40cm Total Abscession Biliary Drainage Catheter (Locking Pigtail)
• 25051684011690: 12F x 40cm Total Abscession Biliary Drainage Catheter (Locking Pigtail)
• 25051684011683: 10F x 40cm Total Abscession Biliary Drainage Catheter (Locking Pigtail)
• 25051684011676: 8F x 40cm Total Abscession Biliary Drainage Catheter (Locking Pigtail)
• 25051684011669: 14F x 45cm Total Abscession Nephrostomy Drainage Catheter (Locking Pigtail)
• 25051684011652: 12F x 45cm Total Abscession Nephrostomy Drainage Catheter (Locking Pigtail)
• 25051684011645: 10F x 45cm Total Abscession Nephrostomy Drainage Catheter (Locking Pigtail)
• 25051684011638: 8F x 45cm Total Abscession Nephrostomy Drainage Catheter (Locking Pigtail)
• 25051684011621: 14F x 30cm Total Abscession Nephrostomy Drainage Catheter (Locking Pigtail)
• 25051684011614: 12F x 30cm Total Abscession Nephrostomy Drainage Catheter (Locking Pigtail)
• 25051684011607: 10F x 30cm Total Abscession Nephrostomy Drainage Catheter (Locking Pigtail)
• 25051684011591: 8F x 30cm Total Abscession Nephrostomy Drainage Catheter (Locking Pigtail)
• 25051684011584: 8F x 30cm Total Abscession Nephrostomy Drainage Catheter (Locking Pigtail)
• 25051684011577: 14F x 45cm Total Abscession General Drainage Catheter (Locking Pigtail)
• 25051684011560: 12F x 45cm Total Abscession General Drainage Catheter (Locking Pigtail)
• 25051684011553: 10F x 45cm Total Abscession General Drainage Catheter (Locking Pigtail)
• 25051684011546: 8F x 45cm Total Abscession General Drainage Catheter (Locking Pigtail)
• 25051684011539: 14F x 30cm Total Abscession General Drainage Catheter (Locking Pigtail)
• 25051684011522: 12F x 30cm Total Abscession General Drainage Catheter (Locking Pigtail)