AngiOptic

GUDID H787106001040

AngiOptic Angiographic Catheter, Pigtail, Non-Braided

ANGIODYNAMICS, INC.

Angiographic catheter, single-use

• Primary Device ID: H787106001040
• NIH Device Record Key: 69bad3e7-0ab7-4aca-bce1-f82cd5c4aa95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AngiOptic
• Version Model Number: 10600104
• 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

Device Dimensions

• Catheter Gauge: 4 French
• Length: 100 Centimeter
• Pressure: 1050 Pound per Square Inch
• Catheter Gauge: 4 French
• Length: 100 Centimeter
• Pressure: 1050 Pound per Square Inch
• Catheter Gauge: 4 French
• Length: 100 Centimeter
• Pressure: 1050 Pound per Square Inch
• Catheter Gauge: 4 French
• Length: 100 Centimeter
• Pressure: 1050 Pound per Square Inch
• Catheter Gauge: 4 French
• Length: 100 Centimeter
• Pressure: 1050 Pound per Square Inch
• Catheter Gauge: 4 French
• Length: 100 Centimeter
• Pressure: 1050 Pound per Square Inch
• Catheter Gauge: 4 French
• Length: 100 Centimeter
• Pressure: 1050 Pound per Square Inch
• Catheter Gauge: 4 French
• Length: 100 Centimeter
• Pressure: 1050 Pound per Square Inch
• Catheter Gauge: 4 French
• Length: 100 Centimeter
• Pressure: 1050 Pound per Square Inch
• Catheter Gauge: 4 French
• Length: 100 Centimeter
• Pressure: 1050 Pound per Square Inch
• Catheter Gauge: 4 French
• Length: 100 Centimeter
• Pressure: 1050 Pound per Square Inch
• Catheter Gauge: 4 French
• Length: 100 Centimeter
• Pressure: 1050 Pound per Square Inch
• Catheter Gauge: 4 French
• Length: 100 Centimeter
• Pressure: 1050 Pound per Square Inch
• Catheter Gauge: 4 French
• Length: 100 Centimeter
• Pressure: 1050 Pound per Square Inch
• Catheter Gauge: 4 French
• Length: 100 Centimeter
• Pressure: 1050 Pound per Square Inch
• Catheter Gauge: 4 French
• Length: 100 Centimeter
• Pressure: 1050 Pound per Square Inch
• Catheter Gauge: 4 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051684003421 [Secondary]
HIBCC	H787106001040 [Primary]
HIBCC	H787106001045 [Package]; Package: BOX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112452

FDA Product Code

• DQO: CATHETER, INTRAVASCULAR, 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: 6
• Public Version Date: 2019-01-14
• Device Publish Date: 2016-09-13

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• H787506001315: AngiOptic Angiographic Catheter, Sos Omni Selective (2), Non-Braided
• H787506001215: AngiOptic Angiographic Catheter, Straight Art, Non-Braided
• H787106323025: AngiOptic Angiographic Catheter, Omni Flush, Non-Braided
• H787106323015: AngiOptic Angiographic Catheter, Omni Flush, Non-Braided
• H787106322045: AngiOptic Angiographic Catheter, Omni Flush, Non-Braided
• H787106322035: AngiOptic Angiographic Catheter, Omni Flush, Non-Braided
• H787106322025: AngiOptic Angiographic Catheter, Omni Flush, Non-Braided
• H787106322015: AngiOptic Angiographic Catheter, Omni Flush, Non-Braided
• H787106110015: AngiOptic Angiographic Catheter, Vertebral, Non-Braided
• H787106099015: AngiOptic Angiographic Catheter, Vertebral, Non-Braided
• H787106098025: AngiOptic Angiographic Catheter, Vertebral, Non-Braided w/ 2 SH
• H787106098015: AngiOptic Angiographic Catheter, Vertebral, Non-Braided w/ 2 SH
• H787106097025: AngiOptic Angiographic Catheter, Vertebral, Non-Braided
• H787106097015: AngiOptic Angiographic Catheter, Vertebral, Non-Braided
• H787106096045: AngiOptic Angiographic Catheter, Straight, Non-Braided
• H787106096035: AngiOptic Angiographic Catheter, Straight, Non-Braided
• H787106096025: AngiOptic Angiographic Catheter, Straight, Non-Braided
• H787106096015: AngiOptic Angiographic Catheter, Straight, Non-Braided
• H787106095085: AngiOptic Angiographic Catheter, Sos Omni (3), Non-Braided w/ 2 SH
• H787106095075: AngiOptic Angiographic Catheter, Sos Omni (2), Non-Braided w/ 2 SH
• H787106095065: AngiOptic Angiographic Catheter, Sos Omni (1), Non-Braided w/ 2 SH
• H787106095055: AngiOptic Angiographic Catheter, Sos Omni (0), Non-Braided w/ 2 SH
• H787106095045: AngiOptic Angiographic Catheter, Sos Omni (3), Non-Braided w/ 2 SH
• H787106095035: AngiOptic Angiographic Catheter, Sos Omni (2), Non-Braided w/ 2 SH
• H787106095025: AngiOptic Angiographic Catheter, Sos Omni (1), Non-Braided w/ 2 SH
• H787106095015: AngiOptic Angiographic Catheter, Sos Omni (0), Non-Braided w/ 2 SH
• H787106094085: AngiOptic Angiographic Catheter, Sos Omni (3), Non-Braided
• H787106094075: AngiOptic Angiographic Catheter, Sos Omni (2), Non-Braided
• H787106094065: AngiOptic Angiographic Catheter, Sos Omni (1), Non-Braided
• H787106094055: AngiOptic Angiographic Catheter, Sos Omni (0), Non-Braided
• H787106094045: AngiOptic Angiographic Catheter, Sos Omni (3), Non-Braided
• H787106094035: AngiOptic Angiographic Catheter, Sos Omni (2), Non-Braided
• H787106094025: AngiOptic Angiographic Catheter, Sos Omni (1), Non-Braided
• H787106094015: AngiOptic Angiographic Catheter, Sos Omni (0), Non-Braided
• H787106093085: AngiOptic Angiographic Catheter, Sidewinder (3), Non-Braided
• H787106093075: AngiOptic Angiographic Catheter, Sidewinder (2), Non-Braided
• H787106093065: AngiOptic Angiographic Catheter, Sidewinder (1), Non-Braided
• H787106093055: AngiOptic Angiographic Catheter, Sidewinder (1), Non-Braided
• H787106093045: AngiOptic Angiographic Catheter, Sidewinder (3), Non-Braided
• H787106093035: AngiOptic Angiographic Catheter, Sidewinder (2), Non-Braided
• H787106093025: AngiOptic Angiographic Catheter, Sidewinder (1), Non-Braided
• H787106093015: AngiOptic Angiographic Catheter, Sidewinder (1), Non-Braided
• H787106092045: AngiOptic Angiographic Catheter, Shepherd Hook (2), Non-Braided
• H787106092035: AngiOptic Angiographic Catheter, Shepherd Hook (1), Non-Braided
• H787106092025: AngiOptic Angiographic Catheter, Shepherd Hook (2), Non-Braided
• H787106092015: AngiOptic Angiographic Catheter, Shepherd Hook (1), Non-Braided
• H787106091025: AngiOptic Angiographic Catheter, Renal, Non-Braided
• H787106091015: AngiOptic Angiographic Catheter, Renal, Non-Braided