CODMAN®

Basic Information

• Brand Name: CODMAN®
• Primary DI: 10381780513490
• Version / Model: 245434
• Catalog Number: 24-5434
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• 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: 927d7979-a577-49f5-809b-f85ff582b5c9

Device Description

CODMAN® Bulk Surgical Strips X-Ray Detectable 1" x 6" (25mm 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HBA	Neurosurgical paddie	Neurology	882.4700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13702	Neurosurgical sponge	A sterile absorbent material intended to be used on the brain to remove blood and other fluids during an operation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00381780513493	GS1
Primary	10381780513490	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			1 Inch x 6 Inch
Device Size Text, specify			25mm x 152mm