FDA.report

OSSEOUS Jobson Horne Probe-Oval

Primary DI
08906039318173
Brand
OSSEOUS Jobson Horne Probe-Oval
Company
EON MEDITECH PRIVATE LIMITED
Model
EI0963
Device description
"Jobson Horne Probe and Cerumen hook are used to hook out wax or foreign bodies from the ear canal. "
Published
2024-07-04
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
JYGCurette, Ear

Product Code Classifications

CodeDeviceSpecialtyClass
JYGCurette, EarEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08906039318173PackageGS1100In Commercial Distribution
08906039319637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08906039318173089060393181738906039318173
08906039319637089060393196378906039319637

GMDN Terms

TermDefinition
Abdominal/ENT/orthopaedic surgical probe, single-useA slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. This is a single-use device.

Device Sizes

TypeValueUnit
Length2.8Millimeter
Length152Millimeter
Width1.34Millimeter

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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