FDA.reportPublic FDA data

Sample, Safe Ear Curette Rainbow Pack

Primary DI
10714646000566
Brand
Sample, Safe Ear Curette Rainbow Pack
Company
Bionix, LLC
Model
25777-9
Catalog number
25777-9
Device description
Sample, Safe Ear Curette Rainbow Pack
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
00714646000569PrimaryGS10
10714646000566Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00714646000569007146460005697146460005690714646000569
1071464600056610714646000566

GMDN Terms#

Term, Definition table
TermDefinition
Endaural wax extraction curetteA hand-held, manual, non-surgical device intended to scrape within the ear canal primarily for the extraction of ear wax during an ear/nose/throat (ENT) procedure; it is not intended for surgical scraping or manipulation of tissues. It may have various designs (e.g., serrated or blunt loop, hook, straight or curved), and may include a magnifying lens and/or light source. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
117844489
Device count
7
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859911004498Safe Ear Curette™ Variety Kit577757772021-12-10
00859911004429Green MicroLoop®122212222021-12-10
00859911004436Orange ControLoop®299929992021-12-10
00859911004443Red AngleLoop®344434442021-12-10
00859911004450Purple VersaLoop®411141112021-12-10
00859911004467Blue InfantScoop®488848882021-12-10
00859911004474Yellow CeraSpoon®633363332021-12-10
00859911004481White FlexLoop®955595552021-12-10
00859911004528Lighted AngleLoop®221022102021-12-10
00859911004535Lighted MicroLoop®222022202021-12-10
00859911004542Lighted WaveCurette™223022302021-12-10
00859911004559Lighted FlexLoop®224022402021-12-10
00859911004566Lighted Ear Curette™ Variety Pack224522452021-12-10
00859911004573Lighted CeraSpoon®225022502021-12-10
00859911004580Lighted InfantScoop®226022602021-12-10
00859911004597Lighted VersaLoop®227022702021-12-10
00859911004603Lighted CeraPik™228022802021-12-10
00859911004702Lighted Forceps for Foreign Body Removal275027502021-12-10
00859911004726Lighted Placement Tool285028502022-08-08
00714646000675Ear Wax Removal Kit7027022024-07-11

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Primary DI, Brand, Company table
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00190776422387MillenniumAvalign Technologies, Inc.JYG2026-07-31
00190776422394MillenniumAvalign Technologies, Inc.JYG2026-07-31
09348811100542INKAThe Trustee for KAISER FAMILY TRUSTJYG2026-07-31