CODMAN HOLTER 821638

GUDID 10886704040576

CODMAN HOLTER Cerebral Catheter-Reservoir LeRoy Design 7cm

CODMAN & SHURTLEFF, INC.

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: 10886704040576
• NIH Device Record Key: 4645185c-88a2-4e5e-846d-0db7e2b9c33d
• Commercial Distribution Discontinuation: 2022-09-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CODMAN HOLTER
• Version Model Number: 82-1638
• Catalog Number: 821638
• Company DUNS: 607846297
• Company Name: CODMAN & SHURTLEFF, INC.
• 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)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
• 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	10886704040576 [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: 3
• Public Version Date: 2022-01-26
• Device Publish Date: 2015-09-20

On-Brand Devices [CODMAN HOLTER]

• 10886704040699: CODMAN HOLTER Peritoneal Catheter Salmon Design
• 10886704040675: CODMAN HOLTER Atrial Catheter Type "E"
• 10886704040668: CODMAN HOLTER Atrial Catheter Type "A"
• 10886704040781: CODMAN HOLTER Lumbo-Peritoneal Shunt, Hoffman Design, 4.1mm
• 10886704040774: CODMAN HOLTER Lumbo-Peritoneal Shunt, Hoffman Design, 3.6mm
• 20886704040740: CODMAN HOLTER Type B Fixation and Joining Connector Straight
• 20886704040733: CODMAN HOLTER Type A Fixation and Joining Connector Straight
• 10886704046202: CODMAN HOLTER Ventricular Catheter with centimeter markings 15cm Contents: Ventricular Catheter,
• 10886704040729: CODMAN HOLTERPeritoneal Catheter Placement Instrument
• 10886704040712: CODMAN HOLTER Distal Catheter Passer
• 10886704040705: CODMAN HOLTER Introducer and Cone Set
• 10886704040651: CODMAN HOLTER Ventricular Catheter 8cm
• 10886704040644: CODMAN HOLTER Ventricular Catheter 7cm
• 10886704040637: CODMAN HOLTER Ventricular Catheter 6cm
• 10886704040620: CODMAN HOLTER Ventricular Catheter 4cm
• 10886704040613: CODMAN HOLTER Ventricular Catheter 3cm
• 10886704040606: CODMAN HOLTER Ventricular Catheter 15cm
• 10886704040767: CODMAN HOLTER In-Line Shunt Filter, Hoffman Design
• 10886704040590: CODMAN HOLTER Cerebral Catheter-Reservoir LeRoy Design 9cm
• 10886704040583: CODMAN HOLTER Cerebral Catheter-Reservoir LeRoy Design 8cm
• 10886704040576: CODMAN HOLTER Cerebral Catheter-Reservoir LeRoy Design 7cm
• 10886704040569: CODMAN HOLTER Cerebral Catheter-Reservoir LeRoy Design 6cm
• 10886704040552: CODMAN HOLTER Cerebral Catheter-Reservoir LeRoy Design 5cm
• 10886704040545: CODMAN HOLTER Cerebral Catheter-Reservoir LeRoy Design 4cm
• 10886704040538: CODMAN HOLTER Cerebral Catheter-Reservoir LeRoy Design 3cm
• 10886704040491: CODMAN HOLTER SELKER Reservoir Large With Nylon Base for 4mm Burr Hole 18.5mm
• 10886704040484: CODMAN HOLTER SELKER Reservoir Standard With Nylon Base for 4mm Burr Hole 14mm