FDA.report

EXMOOR

Primary DI
05060180251925
Brand
EXMOOR
Company
EXMOOR PLASTICS LIMITED
Model
E.301
Catalog number
E301
Device description
Mal Ear Mop
Published
2018-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KXFApplicator, Absorbent Tipped, Non-Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060180251925PackageGS1100In Commercial Distribution
05060180256159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060180251925050601802519255060180251925
05060180256159050601802561595060180256159

GMDN Terms

TermDefinition
Cotton budA 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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep out of direct sunlight.
Special Storage Condition, Specify00Store in a dry environment. Avoid extremes of temperature and humidity.
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius35 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+441823351040sales@exmoorltd.com

Regulatory Flags

DUNS number
298725490
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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05060180250096EXMOORS1010/290S1010/2902018-09-14
05060180250027EXMOORS1010/340S1010/3402018-09-14
05060180250034EXMOORS1010/540S1010/5402018-09-14
05060180250089EXMOORS1011/300S1011/3002018-09-14
05060180250010EXMOORS1011/390S1011/3902018-09-14
05060180250003EXMOORS1012/300S1012/3002018-09-14
05060180250249EXMOORS102S1022018-09-11
05060180250256EXMOORS103S1032018-09-11
05060180250263EXMOORS104S1042018-09-11
05060180250270EXMOORS105S1052018-09-11
05060180250287EXMOORS106S1062018-09-11
05060180250294EXMOORS107S1072018-09-11
05060180250300EXMOORS108S1082018-09-11

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