CODMAN HOLTER 821638

GUDID 10381780517849

CODMAN HOLTER Cerebral Catheter-Reservoir LeRoy Design 7cm

INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir Cranial port/reservoir

• Primary Device ID: 10381780517849
• NIH Device Record Key: 744967c6-86f9-4170-8407-0e3dd476c3d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CODMAN HOLTER
• Version Model Number: 82-1638
• Catalog Number: 821638
• Company DUNS: 081277700
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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
• 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
• 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

• Length: 7 Centimeter
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Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780517849 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102961

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: 2020-05-11
• Device Publish Date: 2020-02-28

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• 10381780518051: CODMAN HOLTER Distal Catheter Passer
• 10381780518044: CODMAN HOLTER Introducer and Cone Set
• 10381780518037: CODMAN HOLTER Peritoneal Catheter Salmon Design
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• 10381780517948: CODMAN HOLTER Ventricular Catheter 8cm
• 10381780517931: CODMAN HOLTER Ventricular Catheter 7cm
• 10381780517924: CODMAN HOLTER Ventricular Catheter 6cm
• 10381780517900: CODMAN HOLTER Ventricular Catheter 4cm
• 10381780517894: CODMAN HOLTER Ventricular Catheter 3cm
• 10381780517887: CODMAN HOLTER Ventricular Catheter 15cm
• 10381780517863: CODMAN HOLTER Cerebral Catheter-Reservoir LeRoy Design 9cm
• 10381780517856: CODMAN HOLTER Cerebral Catheter-Reservoir LeRoy Design 8cm
• 10381780517849: CODMAN HOLTER Cerebral Catheter-Reservoir LeRoy Design 7cm
• 10381780517832: CODMAN HOLTER Cerebral Catheter-Reservoir LeRoy Design 6cm
• 10381780517825: CODMAN HOLTER Cerebral Catheter-Reservoir LeRoy Design 5cm
• 10381780517818: CODMAN HOLTER Cerebral Catheter-Reservoir LeRoy Design 4cm
• 10381780517801: CODMAN HOLTER Cerebral Catheter-Reservoir LeRoy Design 3cm
• 10381780517764: CODMAN HOLTER SELKER Reservoir Large With Nylon Base for 4mm Burr Hole 18.5mm
• 10381780517757: CODMAN HOLTER SELKER Reservoir Standard With Nylon Base for 4mm Burr Hole 14mm