FDA.report

OSSEOUS Suction Tube for Ear-Disposable

Primary DI
08904461003650
Brand
OSSEOUS Suction Tube for Ear-Disposable
Company
EON MEDITECH PRIVATE LIMITED
Model
EI152085
Device description
Suction Tubes for Ear Disposable are for suction of fluid and other media from the ear.
Published
2024-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
JZFTube, Ear Suction

Product Code Classifications

CodeDeviceSpecialtyClass
JZFTube, Ear SuctionEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08904461003650PackageGS110In Commercial Distribution
08904461003582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08904461003650089044610036508904461003650
08904461003582089044610035828904461003582

GMDN Terms

TermDefinition
Ear canal suction handleA noninvasive, non-powered, hand-held device intended to be connected to, and facilitate manipulation of, an appropriate cannula (not included) for suction/removal (aspiration) of debris from the ear canal during an ear/nose/throat (ENT) procedure; it is not intended for irrigation. It is in the form of a cylinder with an inner lumen which may incorporate a side-hole for low-level suction control (e.g., using the thumb); it does not incorporate a switch(es), valve(s) or button(s). It may include connection tubing. This is a single-use device.

Device Sizes

TypeValueUnit
Angle30degree
Length85Millimeter
Outer Diameter2Millimeter

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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