CODMAN EDS 3 821738C

GUDID 10886704079880

CODMAN Lumbar Catheter Kit II (82-1707) with EDS 3 CSF External Drainage System (82-1731C)

CODMAN & SHURTLEFF, INC.

Ventricular cerebrospinal fluid drainage catheterization kit

• Primary Device ID: 10886704079880
• NIH Device Record Key: 9ef8a81f-e376-4527-b01d-8ab0ce8a2448
• Commercial Distribution Discontinuation: 2022-09-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CODMAN EDS 3
• Version Model Number: 82-1738C
• Catalog Number: 821738C
• 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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• Phone: +1(800)255-2500
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Device Identifiers

Device Issuing Agency	Device ID
GS1	10886704079880 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172537

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: 2021-10-12
• Device Publish Date: 2018-09-11

On-Brand Devices [CODMAN EDS 3]

• 10886704040941: CODMAN EDS 3 Clear Ventricular CSF Catheter Includes 35cm Ventricular Catheter, Stylet, Connecto
• 10886704040910: CODMAN EDS 3 CSF External Drainage System
• 10886704040903: CODMAN EDS 3 Clear Ventricular CSF Catheter Includes 35cm Ventricular Catheter, Stylet, Connecto
• 10886704079880: CODMAN Lumbar Catheter Kit II (82-1707) with EDS 3 CSF External Drainage System (82-1731C)
• 10886704079873: CODMAN EDS 3 CSF External Drainage System
• 10886704079866: CODMAN EDS 3 CSF External Drainage System with Ventricular Catheter (REF 82-1735) Clear Ventricu
• 10886704040958: CODMAN Lumbar Catheter Kit II (82-1707) with EDS 3 CSF External Drainage System (82-1731)
• 10886704040934: CODMAN EDS 3 Leveling Device