FDA.reportPublic FDA data

Lighted Ear Curette Demo Pack (monthly mailer)

Primary DI
10714646000641
Brand
Lighted Ear Curette Demo Pack (monthly mailer)
Company
Bionix, LLC
Model
22201
Catalog number
22201
Device description
Lighted Ear Curette Demo Pack (monthly mailer)
Published
2024-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYGCURETTE, EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYGCurette, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00714646000644PrimaryGS10
10714646000641Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00714646000644007146460006447146460006440714646000644
1071464600064110714646000641

GMDN Terms#

Term, Definition table
TermDefinition
ENT illuminating foreign body extraction setA collection of devices which includes a foreign body extraction instrument (typically a curette or forceps), and an electrically-powered light source, and a magnifying lens intended to be inserted into the nasal or ear canal to grip and extract a foreign body/debris (e.g., ear wax) during an ear/nose/throat (ENT) procedure; it is not intended for surgical grasping or manipulation of tissues. This is a reusable set which may include some disposable devices.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)551-7096Bionix@bionix.com

Regulatory Flags#

DUNS number
117844489
Device count
8
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00714646001566ClearLook Variety Pack with Rechargeable Light Source364536452025-11-22
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00714646001597ClearLook CeraSpoon335033502025-11-22
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