CODMAN

Basic Information

• Brand Name: CODMAN
• Primary DI: 10886704036043
• Version / Model: 80-1196
• Catalog Number: 801196
• Company Name: Cerenovus, Inc.
• Labeler DUNS: 607846297
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-30
• Public Version: 6
• Public Version Date: 2023-09-15
• Public Version Status: Update
• Public Device Record Key: 6ad7bfff-8ea0-467e-8568-a69d70a11d2b
• Distribution End Date: 2022-09-01

Device Description

CODMAN Disposable ICP Kit, Plastic, Adult CONTENTS: 1 ICP Screw, 2 Spacing Washers, 1 Handle 1 Retractor, 1 5cc Syringe with 22ga x 1.5 Inches, 1 Drill Assembly 1 Obturator, 1 18ga Spinal Needle 3 Inches, 1 1cc Syringe with 25ga x 5/8 Inch 1 Allen Wrench, 2 Disposable Forceps, 2 Drapes (18 Inches x 26 Inches) 8 4 x 4 Gauze, 1 Bone Wax 2.5gms, 1 Male Luer Lock Cap 1 Number 15 Disposable Scalpel, 1 Fenestrated Drape (24 Inches x 26 Inches)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GWM	DEVICE, MONITORING, INTRACRANIAL PRESSURE	Neurology	882.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61401	Intracerebral catheter cranial-fixation kit	A collection of sterile devices intended to be used to affix an intracerebral sensor/infusion/drainage catheter on the skull of a patient. It includes cranial screws and screwing tools; it does not include the intracerebral catheter, and does not include devices intended for long-term implantation (> 30 days). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10886704036043	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K853770	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 68 – 77 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 68 – 77 Degrees Fahrenheit