EXMOOR

Basic Information

• Brand Name: EXMOOR
• Primary DI: 05060180258740
• Version / Model: E.301CM
• Catalog Number: E301CM
• Company Name: EXMOOR PLASTICS LIMITED
• Labeler DUNS: 298725490
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-27
• Public Version: 2
• Public Version Date: 2019-10-15
• Public Version Status: Update
• Public Device Record Key: a40a0508-4b8d-49cb-96e8-4899a91edebd

Device Description

Mal Ear Mop

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: 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	880.6025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46743	Cotton bud	A device typically designed as an absorbent, non-sterile pledget of cotton on a wooden, paper, or plastic stick, with a single- or a double-ended tip, intended to be used within the healthcare sector or the home, or within the manufacturing/service industries. Commonly known as cotton buds, it has uses that range from cleaning wax from the outer ear canal, to applying substances/cosmetics to the body, to cleaning electronics. It is used within the healthcare sector or the home and is normally available [non-prescription] over-the-counter (OTC). This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05060180253158	GS1	a box	100	In Commercial Distribution
Primary	05060180258740	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dry environment. Avoid extremes of temperature and humidity.
• Type: Special Storage Condition, Specify
• Special Conditions: Keep out of direct sunlight.