CODMAN SIPHONGUARD 823090

GUDID 10886704041399

CODMAN SIPHONGUARD CSF Control Device

CODMAN & SHURTLEFF, INC.

Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve Cerebrospinal fluid shunt valve

• Primary Device ID: 10886704041399
• NIH Device Record Key: f18e3b5a-c5d4-4f44-b007-fd0f2ec67ddf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CODMAN SIPHONGUARD
• Version Model Number: 82-3090
• Catalog Number: 823090
• Company DUNS: 607846297
• Company Name: CODMAN & SHURTLEFF, 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(800)255-2500
• Email: xx@xx.xx
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• Phone: +1(800)255-2500
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Device Identifiers

Device Issuing Agency	Device ID
GS1	10886704041399 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053107

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: 3
• Public Version Date: 2021-04-07
• Device Publish Date: 2015-09-20

Devices Manufactured by CODMAN & SHURTLEFF, INC.

• 10886704085355 - CEREGLIDE: 2023-07-17 CEREGLIDE 71 Intermediate Catheter 115 cm 0.071 in (1.80 mm) 0.0820 in (2.08 mm) 0.0825 in (2.10 mm)
• 10886704085386 - CEREGLIDE: 2023-07-17 CEREGLIDE 71 Intermediate Catheter 137 cm 0.071 in (1.80 mm) 0.0820 in (2.08 mm) 0.0825 in (2.10 mm)
• 10886704085409 - CEREGLIDE: 2023-07-17 CEREGLIDE 71 Intermediate Catheter 132 cm 0.071 in (1.80 mm) 0.0820 in (2.08 mm) 0.0825 in (2.10 mm)
• 10886704085423 - CEREGLIDE: 2023-07-17 CEREGLIDE 71 Intermediate Catheter 125 cm 0.071 in (1.80 mm) 0.0820 in (2.08 mm) 0.0825 in (2.10 mm)
• 10886704078630 - CODMAN MALIS CMC: 2023-04-04 CODMAN MALIS CMC-V Generator
• 10886704046912 - CODMAN HAKIM RICKHAM: 2022-10-10 CODMAN HAKIM Precision Fixed Pressure Valve MICRO II With Large RICKHAM Reservoir Operating Pressure: 100mm H2O Plus or Minus 10
• 10886704045366 - CODMAN HAKIM SIPHONGUARD: 2022-09-01 CODMAN HAKIM Precision Fixed Pressure Valve with SIPHONGUARD Device Operating Pressure: 130mm H2O High Range Includes: Ventricul
• 10886704015505 - CRANIOPLASTIC: 2022-03-01 Codman CRANIOPLASTIC Resinous Material for Repairing Cranial Defects