CODMAN® 82-3044

GUDID 10381780518822

Atrial Catheter

INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter Atrial cerebrospinal fluid catheter

• Primary Device ID: 10381780518822
• NIH Device Record Key: 731e5b5b-95ec-4991-81d7-978cdcaa1440
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CODMAN®
• Version Model Number: 823044
• Catalog Number: 82-3044
• Company DUNS: 081277700
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• 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)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French
• Catheter Length: 46 Centimeter
• Catheter Inner Diameter: 1 Millimeter
• Catheter Gauge: 66 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780518822 [Primary]
GS1	10886704041269 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944222

FDA Product Code

• JXG: Shunt, central nervous system and components

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-02-05
• Device Publish Date: 2020-06-02

On-Brand Devices [CODMAN®]

• 10381780530374: Electrosurgical Circular Foot Pedal
• 10381780520313: CODMAN ACCU-FLO James Lumbar Peritoneal Shunt 80cm Medium Closing Pressure 5-9cm H2O
• 10381780520306: CODMAN ACCU-FLO James Lumbar Peritoneal Shunt 50cm Medium Closing Pressure 5-9cm H2O
• 10381780520290: CODMAN ACCU-FLO James Lumbar Peritoneal Shunt 25cm Medium Closing Pressure 5-9cm H2O
• 10381780520283: CODMAN ACCU-FLO 1 CSF Reservoir 24mm 1 Barium Ventricular Catheter, 1 Connector, Straight Barium
• 10381780520276: CODMAN ACCU-FLO 1 CSF Reservoir 14mm 1 Barium Ventricular Catheter, 1 Connector, Straight Barium
• 10381780532880: Electrosurgical Generator
• 10381780532873: Electrosurgical Irrigator
• 10381780532866: Electrosurgical Foot Pedal
• 00381780521788: Integrated Bipolar Cord and Tubing Set Flying Leads, Rotary Pump, Bulk
• 00381780521771: Integrated Bipolar Cord and Tubing Set Flying Leads, Rotary Pump
• 00381780521764: Integrated Bipolar Cord and Tubing Set Flying Leads, Gravity Feed, Bulk
• 00381780521757: Integrated Bipolar Cord and Tubing Set Flying Leads, Gravity Feed
• 00381780521740: Integrated Bipolar Cord and Tubing Set Fixed Leads, Rotary Pump
• 00381780521733: Integrated Bipolar Cord and Tubing Set Fixed Leads, Gravity Feed
• 00381780521412: Peel-Away Catheter Introducer 14 FR.
• 00381780521405: Peel-Away Catheter Introducer 12.5 FR.
• 00381780521399: Peel-Away Catheter Introducer 9 Fr.
• 10381780520351: Cranial Drill Bit 2.7mm
• 10381780520344: Cranial Drill Bit 5.8mm
• 10381780520337: Cranial Hand Drill
• 10381780519942: Disposable Split Trocar
• 10381780515708: Right Angle Cranial Clip with Tabs
• 10381780515500: Disposable Catheter Passer 65cm
• 10381780515494: Disposable Catheter Passer 55cm
• 10381780515487: Disposable Catheter Passer 36cm
• 00381780515138: Surgical Strips 3 1/2 Inches x 6 Inches (89mm x 152mm)
• 00381780515121: Surgical Strips 3 Inches x 6 Inches (76mm x 152mm)
• 00381780515114: Surgical Strips 2 Inches x 6 Inches (51mm x 152mm)
• 00381780515107: Surgical Strips 1 1/2 Inches x 6 Inches (38mm x 152mm)
• 00381780515091: Surgical Strips 1 Inch x 6 Inches (25mm x 152mm)
• 00381780515084: Surgical Strips 3/4 Inch x 6 Inches (19mm x 152mm)
• 00381780515077: Surgical Strips 1/2 Inch x 6 Inches (13mm x 152mm)
• 00381780515060: Surgical Strips 1/4 Inch x 6 Inches (6mm x 152mm)
• 00381780515053: Surgical Strips 1/8 Inch x 6 Inches (3mm x 152mm)
• 00381780515046: Surgical Patties 3 Inches x 3 Inches (7.62cm x 7.62cm)
• 00381780515039: Surgical Patties 1 Inch x 3 Inches (2.54cm x 7.62cm)
• 00381780515022: Surgical Patties 1/2 Inch x 3 Inches (1.27cm x 7.62cm)
• 00381780515015: Surgical Patties 1/2 Inch x 2 Inches (1.27cm x 5.08cm)
• 00381780515008: Surgical Patties 1/2 Inch x 1 1/2 Inches (1.27cm x 3.81cm)
• 00381780514995: Surgical Patties 1 Inch x 1 Inch (2.54cm x 2.54cm)
• 00381780514988: Surgical Patties 1/2 Inch x 1 Inch (1.27cm x 2.54cm)
• 00381780514971: Surgical Patties 3/4 Inch x 3/4 Inch (1.91cm x 1.91cm)
• 00381780514964: Surgical Patties 1/2 Inch x 1/2 Inch (1.27cm x 1.27cm)
• 00381780514957: Surgical Patties 1/4 Inch x 1/4 Inch (0.64cm x 0.64cm)
• 00381780514940: Surgical Patties 1/4 Inch x 3 Inches (0.64cm x 7.62cm)
• 00381780514933: Surgical Patties 1/4 Inch x 1 1/2 Inches (0.64cm x 3.81cm)
• 00381780514926: Surgical Patties 5/16 Inch (0.79cm) Dia.
• 10381780514879: Disposable ICP Kit, Plastic, Pediatric CONTENTS: 1 ICP Plastic Screw, 1 Spacing Washer, 1 Handle
• 10381780514831: Disposable ICP Kit, Plastic, Adult CONTENTS: 1 ICP Screw, 2 Spacing Washers, 1 Handle 1 Retracto