FDA.reportPublic FDA data

EXMOOR

Primary DI
05060180256043
Brand
EXMOOR
Company
EXMOOR PLASTICS LIMITED
Model
E.111
Catalog number
E111 or E111X5
Device description
Aural Grommet
Published
2018-09-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETDTube, Tympanostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETDTube, TympanostomyEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K911580000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K911580000DONALDSON/SHEPARDS DR/COLLAR/SHAH VENT-MINI TUBESExmoor Plastics , Ltd.1991-09-24ETD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060180251567PackageGS125Not in Commercial Distribution
05060180256685PackageGS15Not in Commercial Distribution
05060180256043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060180251567050601802515675060180251567
05060180256685050601802566855060180256685
05060180256043050601802560435060180256043

GMDN Terms#

Term, Definition table
TermDefinition
Tympanostomy tubeA small, hollow cylinder intended to be implanted, by insertion through the tympanic membrane, for ventilation or drainage of the middle ear. Otherwise known as a myringotomy tube, grommet or an aural vent tube, it is made of materials such as polytetrafluoroethylene (PTFE), polyethylene (PE), silicon elastomer, or porous polyethylene. One type, known as the malleus clip tube, attaches to the malleus. Disposable devices associated with implantation may be included with the device, which may be used to implant bilateral tubes.

Storage And Handling#

Type, Low, High table
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 Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+441823351040sales@exmoorltd.com

Regulatory Flags#

DUNS number
298725490
Device count
1
DM exempt
false
Premarket exempt
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060180256180EXMOORE402E4022018-09-11
05060180256272EXMOORE.59E592018-09-20
05060180256319EXMOORL1L12018-09-10
05060180257798EXMOORS101S101-EX2018-09-11
05060180257866EXMOORS102S102-EX2018-09-11
05060180257873EXMOORS103S103-EX2018-09-11
05060180257880EXMOORS104S104-EX2018-09-11
05060180257934EXMOORS109S109-EX2018-09-11
05060180257972EXMOORS110S110-EX2018-09-11
05060180257989EXMOORS111S111-EX2018-09-11
05060180258139EXMOORS125S125-EX2018-09-11
05060180256258EXMOORE.58E582018-09-20
05060180256265EXMOORE.58aE58A2018-09-20
05060180256159EXMOORE.301E3012018-09-10
05060180251048EXMOORN18N182018-09-14
05060180251062EXMOORN23N232018-09-17
05060180251642EXMOORMK/82/A/E107MK82AE1072018-10-09
05060180251659EXMOORMK/82/A/E108MK82AE1082018-10-09
05060180252083EXMOORE.302E.3022018-09-21
05060180252106EXMOORSRS.6a(29)SRS6A(29)2018-09-21

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