Pkit, Hana & ProFx, W/Boot Liner

Basic Information

• Brand Name: Pkit, Hana & ProFx, W/Boot Liner
• Primary DI: 00842430101878
• Version / Model: 6851-1
• Catalog Number: 6851
• Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Labeler DUNS: 084527241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-22
• Public Version: 3
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: f64e8c89-5b6f-4c52-8bce-0e1d62efd9fa

Device Description

Patient Care Kit includes a Supine-Lateral Headrest Pillow, a Padded Perineal Post Cover, a pair of Armboard Pads and Soft Straps, a pair of Ball Joint Fluid Protectors, and a pair of boot liners.

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: Yes
• 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
CCX	Support, Patient Position	Anesthesiology	868.6820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62619	Surgical linen/cushion set	A collection of devices intended to be fitted to equipment used to support a patient during surgery (e.g., operating table) to provide a hygienic barrier and positioning/support capabilities. It typically includes operating table sheets, covers, pillows/cushions, foam pads, and equipment drapes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10842430101875	GS1	bulk pack	6	In Commercial Distribution
Primary	00842430101878	GS1

Customer Contacts

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