CODMAN FLEX1 70028

GUDID 10886704034995

Replacement Connector with Strain Relief Sleeve

CODMAN & SHURTLEFF, INC.

Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter Spinal infusion/drainage catheter

• Primary Device ID: 10886704034995
• NIH Device Record Key: ffeb7683-a6ee-4518-bad7-692235de8b97
• Commercial Distribution Discontinuation: 2017-09-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CODMAN FLEX1
• Version Model Number: 70028
• Catalog Number: 70028
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886704034995 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P890055

FDA Product Code

• LKK: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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: 2022-01-31
• Device Publish Date: 2014-09-20

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