EXMOOR

Basic Information

• Brand Name: EXMOOR
• Primary DI: 05060180259105
• Version / Model: MK/82/A/E102
• Catalog Number: MK82AE102
• Company Name: EXMOOR PLASTICS LIMITED
• Labeler DUNS: 298725490
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-09
• Public Version: 3
• Public Version Date: 2019-06-10
• Public Version Status: Update
• Public Device Record Key: 3aec8499-a371-47ac-9e56-bad2c477531f

Device Description

Myringotomy Kit with Grommets

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JYP	Knife, Myringotomy	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13846	Secretion suction kit	A collection of items intended for suctioning secretions from a patient; typically included are sterile gloves, a suction catheter, and a container for collecting the secretions. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05060180253646	GS1	a box	10	In Commercial Distribution
Primary	05060180259105	GS1

Customer Contacts

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

Storage Conditions

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