CODMAN

Basic Information

• Brand Name: CODMAN
• Primary DI: 10886704001171
• Version / Model: 20-1039
• Catalog Number: 201039
• 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: edb6ecce-a7bc-463c-af63-170941072bfa
• Distribution End Date: 2022-09-01

Device Description

CODMAN Scalp Clip Removal Forceps

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HBO	CLIP, SCALP	Neurology	882.4150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46950	Scalp clip forceps	A hand-held, manually-operated, surgical instrument used to manually apply and remove haemostatic scalp clips (reusable or single-use) from the scalp during or after a surgical intervention on the cranium/scalp. It is typically a scissors-like device with ring handles, and may or may not be self-retaining. The working end of the device will typically have dedicated grasping blades that are profiled/designed to accommodate a compatible scalp clip. The device is available in various sizes and is typically made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10886704001171	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K905433	000