Insight

Basic Information

• Brand Name: Insight
• Primary DI: 00817517026894
• Version / Model: 138016
• Company Name: MARKETLAB INC.
• Labeler DUNS: 848917027
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-08
• Public Version: 2
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: ae5dc408-0c0a-41bc-a155-26512e676746

Device Description

Insight GynoCart Exam Cart

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: 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LGX	Table, Examination, Medical, Powered	General, Plastic Surgery	878.4960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36614	Examination/operating table component trolley	A dedicated cart designed as a framework on wheels intended to transport a component/accessory of an examination and/or operating table (e.g., patient supports, stirrups, tabletops) within a hospital/institution department or ward. It may include baskets, shelves, hooks and/or organizers for storing and/or transporting components. This trolley (cart) may be used in association with an examination/operating table and may have a fixed height or be hydraulically height-adjustable by a pump (e.g., to position a tabletop onto or off a column). It is not intended to be used to perform procedures.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817517026894	GS1