Endorectal Coil Holder Repair Kit

Basic Information

• Brand Name: Endorectal Coil Holder Repair Kit
• Primary DI: 04260487680447
• Version / Model: ZUB-01979
• Catalog Number: none
• Company Name: RAPID Biomedical GmbH
• Labeler DUNS: 316037741
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-09
• Public Version: 1
• Public Version Date: 2020-03-17
• Public Version Status: New
• Public Device Record Key: df84c1f7-8182-479b-b702-ff5ef266570a

Device Description

ER Coil Holder Repair Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• 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
MOS	Coil, Magnetic Resonance, Specialty	Radiology	892.1000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40749	MRI system coil, radio-frequency	A radio-frequency (RF) coil acts as a transmitter, receiver, or both a transmitter and receiver of RF pulses necessary for diagnostic magnetic resonance imaging (MRI) procedures. It is used to enhance image resolution by improving signal to noise characteristics. There are two main kinds of RF coils: volume coils (which surround the part of the body being imaged) and surface coils (which are placed and secured directly on or under an area of interest). This group of devices includes a variety RF coil designs and configurations including, e.g., surface coils, phased array coils, paired saddle coils, Hemholtz pair coils or bird cage coils.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260487680447	GS1

Premarket Submissions

Submission Number	Supplement Number
K191539	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 24 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 59 – 75.2 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 30 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 107 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -25 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -13 – 140 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity