CODMAN®

Basic Information

• Brand Name: CODMAN®
• Primary DI: 10381780515135
• Version / Model: 801457
• Catalog Number: 80-1457
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2020-04-01
• Public Version: 6
• Public Version Date: 2023-04-14
• Public Version Status: Update
• Public Device Record Key: 8e9f94eb-c052-4377-8e39-2970c8322e86

Device Description

CODMAN® Surgical Strips 3 1/2" x 6" (89mm x 152mm)

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: Yes
• 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
HBA	Neurosurgical paddie	Neurology	882.4700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61854	Intracerebral cannula, nonimplantable, reusable	A nonimplantable, rigid tube intended to be surgically inserted through the skull to access the brain (e.g., cerebral ventricles) for cerebrospinal fluid (CSF) drainage, infusion of materials, and/or for use as a port through which instruments, leads and/or probes can be passed to perform a variety of diagnostic, treatment, or surgical procedures. It is usually made of metal (e.g., stainless steel) and may include a stylet/trocar blade. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00381780515138	GS1
Primary	10381780515135	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K880402	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			89mm x 152mm
Device Size Text, specify			3 1/2 Inch x 6 Inch