FDA.reportPublic FDA data

EarClear Rx

Primary DI
00856331006231
Brand
EarClear Rx
Company
NUANCE MEDICAL, LLC
Model
90004
Catalog number
90004
Device description
EarClear Rx Ear Wash Kit Rigid
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
KCPSYRINGE, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCPSyringe, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856331006231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856331006231008563310062318563310062310856331006231

GMDN Terms#

Term, Definition table
TermDefinition
Medical capital equipment storage bag/caseA non-sterile, portable, protective container intended to be used by a healthcare provider to store/transport a piece of medical capital equipment (not included) between uses, and may in addition be intended to hold some device components during use; it is not intended to be worn by a patient to hold a personal medical device. It is a durable bag or case with a padded interior intended to prevent damage to medical devices. It is often designed to contain a specific type of device, however it does not include specific parent-device-supportive medical accessories, and is not intended to shield radiation. 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

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00194613021535MSI Precision Specialty InstrumentsMed Saver, Inc.KCP2025-08-01
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00757770436620Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00757770457588Bausch + LombBausch & Lomb IncorporatedKCP2025-07-29
00661392010444LSL HEALTHCARELSL Industries, LLCKCP2025-05-16
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