Total Abscession

GUDID H787140009025

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

ANGIODYNAMICS, INC.

Biliary drainage catheter Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain Biliary drain

• Primary Device ID: H787140009025
• NIH Device Record Key: 36bac1e2-f621-4fc6-ac3a-80934de716d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Total Abscession
• Version Model Number: 14000902
• Company DUNS: 079105071
• 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(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051684011686 [Secondary]
HIBCC	H787140009020 [Primary]
HIBCC	H787140009025 [Package]; Contains: H787140009020; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060023

FDA Product Code

• FGE: CATHETER, BILIARY, DIAGNOSTIC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-12
• Device Publish Date: 2015-09-16

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)