Halyard

Basic Information

• Brand Name: Halyard
• Primary DI: 20680651473183
• Version / Model: 47318
• Catalog Number: 47318
• Company Name: O&M HALYARD, INC.
• Labeler DUNS: 081057389
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2020-11-16
• Public Version: 2
• Public Version Date: 2021-12-22
• Public Version Status: Update
• Public Device Record Key: fc41dd6a-4b88-4500-8a71-b63aebbb6d95

Device Description

HALYARD* COVER MAX Surgical Cap

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FYF	CAP, SURGICAL	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32297	Surgical cap, single-use	A head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering in other healthcare settings. It is usually made of reinforced paper or non-woven materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30680651473180	GS1	CS	3	In Commercial Distribution
Primary	20680651473183	GS1
Unit of Use	90680651473182	GS1

Customer Contacts

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