FDA.report

OSSEOUS

Primary DI
08906039313383
Brand
OSSEOUS
Company
EON MEDITECH PRIVATE LIMITED
Model
E7162
Device description
Ear PVA Dressings sponges are designed to be placed inside ear canal for use as temporary tamponade or heamostatis device to control blood oozing or persistent bleeding and aid the treatment of otitis external.
Published
2024-06-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KCNEar Wick

Product Code Classifications

CodeDeviceSpecialtyClass
KCNEar WickEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08904428717903PackageGS110In Commercial Distribution
08906039313383PackageGS120In Commercial Distribution
08906039310627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08904428717903089044287179038904428717903
08906039313383089060393133838906039313383
08906039310627089060393106278906039310627

GMDN Terms

TermDefinition
Ear wick, non-biodegradableA non-biodegradable packing material [e.g., loosely twisted unspun cotton, gauze, or polyvinyl alcohol (PVA)] intended to be used in the ear of a patient after internal ear surgery, and/or to administer medicinal substances to the ear to treat ear disorders. This is a single-use device.

Device Sizes

TypeValueUnit
Length24Millimeter
Outer Diameter9Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
930270428
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
true
Sterilization required before use
false

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08904428798292OSSEOUS- TouchFree HME Series - StandardEA9100112026-03-13
08906039318012OSSEOUS-Heat Moisture Exchanger-AirEA910012026-03-13
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08904428747665OSSEOUS Blade - Inferior turbinate - N TypeEI22212024-07-10
08904428747658OSSEOUS Blade-Straight Sinus Blades - N TypeEI22202024-07-10
08904428747641OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N TypeEI22192024-07-10
08904428747634OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N TypeEI22182024-07-10
08904428747627OSSEOUS Blade-Curved Sinus Blades - TypeEI22172024-07-10

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