ErgoJust LTM & ICU

Basic Information

• Brand Name: ErgoJust LTM & ICU
• Primary DI: 00382830058377
• Version / Model: IP-EC-VIDEO-EXT
• Company Name: XLTEK
• Labeler DUNS: 245258280
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-10
• Public Version: 1
• Public Version Date: 2023-11-20
• Public Version Status: New
• Public Device Record Key: f37d99cb-dadb-493b-8b33-b643f2766100

Device Description

IP PTZ ErgoJust Video Extension

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
GDC	Table, Operating-Room, Electrical	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	00382830058377	GS1