ADANTE KNEE PROCEDURE KIT, RIGHT

Basic Information

• Brand Name: ADANTE KNEE PROCEDURE KIT, RIGHT
• Primary DI: 00842430109157
• Version / Model: 6895K-R
• Catalog Number: 6895K-R
• Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Labeler DUNS: 084527241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-28
• Public Version: 1
• Public Version Date: 2025-08-05
• Public Version Status: New
• Public Device Record Key: c71aa12d-56c4-418a-81b4-942d8894ad75

Device Description

Contains 6895TKA-L-CS Adante Knee Drape System, Right (case of 5) and 6895-75-5 Adante Knee Protection Kit (case of 5)

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: Yes
• 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
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
Primary	00842430109157	GS1

Customer Contacts

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