De Mayo Knee Positioner®

Basic Information

• Brand Name: De Mayo Knee Positioner®
• Primary DI: 00696588002880
• Version / Model: 803-GP-10
• Catalog Number: 803-GP-10
• Company Name: Innovative Medical Products, Inc
• Labeler DUNS: 147363154
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-09-25
• Public Version: 3
• Public Version Date: 2024-01-15
• Public Version Status: Update
• Public Device Record Key: 84caad7c-aea4-4fb5-a6e4-73b97c1d067d

Device Description

Sterile Patient Protective Pad for IMP® Knee Positioners & Cohesive Wrap (10 / Case)

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: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMP	Protector, Skin Pressure	General Hospital	880.6450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48139	Orthopaedic knee/leg holder liner	A sterile pad/cover designed to be placed between a patient's leg and an orthopaedic knee/leg holder, cushioning the leg to reduce the risk of damage of the skin/muscles/nerves during an orthopaedic procedure (e.g., arthroscopy, arthroplasty). It is typically made of disposable plastic material (e.g., a foam) with an appropriate shape and size to fit the holder. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00696588002880	GS1
Unit of Use	00696588002873	GS1