ENDORO DR ES70 X-ray Source

Basic Information

• Brand Name: ENDORO DR ES70 X-ray Source
• Primary DI: 08800060100236
• Version / Model: ES70
• Company Name: REMEDI CO.,LTD.
• Labeler DUNS: 690072489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-23
• Public Version: 1
• Public Version Date: 2024-07-31
• Public Version Status: New
• Public Device Record Key: 833eaffe-bd38-4c33-9408-6020bcdb73dd

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IZI	System, X-Ray, Angiographic	Radiology	892.1600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37643	Portable basic diagnostic x-ray system, digital	An assembly of devices that comprise a general-purpose portable diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The portable design allows it to operate on either mains or battery power and to be easily disassembled, moved from location to another, and easily reassembled for use. It consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800060100236	GS1

Premarket Submissions

Submission Number	Supplement Number
K212144	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 76 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 5 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 15 – 40 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 76 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius