Mindray

Basic Information

• Brand Name: Mindray
• Primary DI: 06948350529496
• Version / Model: A27XXU Meniscus positioning device
• Company Name: Nanjing Mindray Bio-Medical Electronics Co.,Ltd
• Labeler DUNS: 420323304
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-22
• Public Version: 1
• Public Version Date: 2025-09-30
• Public Version Status: New
• Public Device Record Key: 3ec4a336-8f80-471e-908c-47c0e23b9a17

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	878.4960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55836	Leg procedure positioner	A non-powered, patient-contact, preformed device (e.g., holder, sling, cushion, foam pad, wedge, multi-jointed structure) designed to be attached to an operating table to stabilize a patient's leg (e.g., thigh, knee, ankle) for adequate positioning and support of the body part during a medical/surgical procedure (e.g., orthopaedic surgery, examination, office procedure), or during patient transfer to an operating table; it is not intended for application of traction forces. It is typically padded to avoid damage of the skin/muscles/nerves, and components for attachment to the operating/examination table are typically included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06948350529496	GS1