OSSEOUS-Ear/Nasal Extractor

GUDID 08904461031073

Nasal Extractor is designed and intended principally for extraction of impacted foreign bodies in the nasal passages. This device may also be used in the external ear canal, based upon clinical judgment.

EON MEDITECH PRIVATE LIMITED

ENT foreign body inflatable extractor
Primary Device ID08904461031073
NIH Device Record Key5bf8f03d-427c-4d4e-8015-b4d1d3e8622f
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSSEOUS-Ear/Nasal Extractor
Version Model NumberE3149
Company DUNS930270428
Company NameEON MEDITECH PRIVATE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 25 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 0 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108904461031073 [Package]
Contains: 08904461031080
Package: Laminated Box [5 Units]
In Commercial Distribution
GS108904461031080 [Primary]

FDA Product Code

LRCInstrument, Ent Manual Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-23
Device Publish Date2026-03-13

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