FDA.reportPublic FDA data

EarClear Rx

Primary DI
00856331006170
Brand
EarClear Rx
Company
NUANCE MEDICAL, LLC
Model
90001
Catalog number
90001
Device description
EarClear Rx Ear Wash Basin
Published
2018-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FNYBASIN, EMESIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNYBasin, EmesisGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856331006170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856331006170008563310061708563310061700856331006170

GMDN Terms#

Term, Definition table
TermDefinition
Ear bowlA bowl specifically designed to be used for treatment of the ear(s), e.g., irrigation of the outer ear canal during a ear/nose/throat (ENT) procedure. It is usually constructed to fit the curvature of the head so that it will sit closely under the ear lobe and is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(760)585-4849george@cryodose.com

Regulatory Flags#

DUNS number
078797666
Device count
1
DM exempt
true
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856331006217EarClear Rx90006900062018-10-25
00856331006224EarClear Rx90007900072018-10-25
00856331006149CryoDose TA180218022017-03-06
00856331006156CryoDose TA180318032017-03-06
00856331006163CryoDose TA180418042017-03-06
00856331006248CryoDose TA180518052018-10-25
00856331006002CryoDose110011002016-10-03
00856331006026CryoDose110111012016-10-03
00856331006033CryoDose110311032016-10-03
00856331006040CryoDose150015002016-10-03
00856331006057CryoDose150115012016-10-03
00856331006064CryoDose1101102016-10-03
00856331006071CryoDose1501502016-10-03
00856331006088CryoDose H1703751703752016-10-03
00856331006095CryoDose H1702931702932016-10-03
00856331006101CryoDose H1702941702942016-10-03
00856331006118CryoDose H1702951702952016-10-03
00856331006125CryoDose H1701001701002016-10-03
00856331006132CryoDose H1701021701022016-10-03
00856331006187EarClear Rx90002900022018-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918130552AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2026-04-17
10198956251335CARDINAL HEALTHCardinal Health 200, LLCFNY2026-01-12
10198956251342CARDINAL HEALTHCardinal Health 200, LLCFNY2026-01-12
10198956251359CARDINAL HEALTHCardinal Health 200, LLCFNY2025-12-10
10198956138193CARDINAL HEALTHCardinal Health 200, LLCFNY2025-11-07
00661392001176LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392012356LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392012752LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392037977LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392053823LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392055063LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
10198956137714CARDINAL HEALTHCardinal Health 200, LLCFNY2025-08-28
16931918189192AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-21
16931918190082AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-21
16931918129310AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
16931918140827AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
16931918145464AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
16931918146843Beaver Visitec InterGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
16931918157085AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
00661392008083LSL HEALTHCARELSL Industries, LLCFNY2025-05-16
00661392025493LSL HEALTHCARELSL Industries, LLCFNY2025-05-16
00661392045330LSL HEALTHCARELSL Industries, LLCFNY2025-05-16
00661392027664LSL HEALTHCARELSL Industries, LLCFNY2025-05-15
00661392004627LSL HEALTHCARELSL Industries, LLCFNY2025-04-22
10198956044890CARDINAL HEALTHCardinal Health 200, LLCFNY2025-04-03
10197106833780CARDINAL HEALTHCardinal Health 200, LLCFNY2024-12-31
10840330701355ProCureTwin Med, LLCFNY2024-11-14
10840330701362ProCureTwin Med, LLCFNY2024-11-14
10840330701379ProCureTwin Med, LLCFNY2024-11-14
10840330701386ProCureTwin Med, LLCFNY2024-11-14