Pkit, Hana and ProFx

Basic Information

• Brand Name: Pkit, Hana and ProFx
• Primary DI: 00842430101700
• Version / Model: 6855-1
• Catalog Number: 6855, 6855-3
• Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Labeler DUNS: 084527241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-18
• Public Version: 5
• Public Version Date: 2023-09-11
• Public Version Status: Update
• Public Device Record Key: 4bce736e-cb01-4af2-bcb0-cbeea044d01b

Device Description

6855-3 (GTIN: 20842430101704) included 3 packs of 6855-1 (GTIN: 842430101700) 6855 (GTIN: 10842430101707) included 6 packs of 6855-1 (GTIN: 842430101700)

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	20842430101704	GS1	case	3	In Commercial Distribution
Primary	00842430101700	GS1
Package	10842430101707	GS1	case	6	In Commercial Distribution

Customer Contacts

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