Halyard

Basic Information

• Brand Name: Halyard
• Primary DI: 10680651292244
• Version / Model: 29224
• Catalog Number: 29224NS
• Company Name: O&M HALYARD, INC.
• Labeler DUNS: 081057389
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-23
• Public Version: 1
• Public Version Date: 2019-10-31
• Public Version Status: New
• Public Device Record Key: c8b2322d-98c9-48bf-b95f-9fba616f6713

Device Description

Universal Spine Drape

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: No
• 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
PUI	Drape, surgical, exempt	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47782	Patient surgical drape, single-use, non-sterile	A non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a single-use device intended to be sterilized prior to use.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30680651292248	GS1	CS	9	In Commercial Distribution
Primary	10680651292244	GS1

Customer Contacts

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