Total Abscession

GUDID H787140008275

8F x 45cm Total Abscession General Drainage Catheter (Locking Pigtail)

ANGIODYNAMICS, INC.

Closed-wound drain Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable

• Primary Device ID: H787140008275
• NIH Device Record Key: 9728411d-9750-48ec-9022-9b095b1cf218
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Total Abscession
• Version Model Number: 14000827
• Company DUNS: 079105071
• Company Name: ANGIODYNAMICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Dimensions

• Length: 45 Centimeter
• Catheter Gauge: 8 French
• Length: 45 Centimeter
• Catheter Gauge: 8 French
• Length: 45 Centimeter
• Catheter Gauge: 8 French
• Length: 45 Centimeter
• Catheter Gauge: 8 French
• Length: 45 Centimeter
• Catheter Gauge: 8 French
• Length: 45 Centimeter
• Catheter Gauge: 8 French
• Length: 45 Centimeter
• Catheter Gauge: 8 French
• Length: 45 Centimeter
• Catheter Gauge: 8 French
• Length: 45 Centimeter
• Catheter Gauge: 8 French
• Length: 45 Centimeter
• Catheter Gauge: 8 French
• Length: 45 Centimeter
• Catheter Gauge: 8 French
• Length: 45 Centimeter
• Catheter Gauge: 8 French
• Length: 45 Centimeter
• Catheter Gauge: 8 French
• Length: 45 Centimeter
• Catheter Gauge: 8 French
• Length: 45 Centimeter
• Catheter Gauge: 8 French
• Length: 45 Centimeter
• Catheter Gauge: 8 French
• Length: 45 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051684011549 [Secondary]
HIBCC	H787140008270 [Primary]
HIBCC	H787140008275 [Package]; Contains: H787140008270; Package: BOX [5 Units]; In Commercial Distribution

FDA Product Code

• GBX: CATHETER, IRRIGATION

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: 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)