EARGO

Primary DI
10850010429189
Brand
EARGO
Company
Eargo, Inc.
Model
99-0113-001
Catalog number
99-0113-001
Device description
EARGO NEO ACCESSORY KIT, FLEXI PALM, SIZE SMALL
Published
2020-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ESDHearing aid, air conduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESDHearing Aid, Air-Conduction, PrescriptionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850010429182PrimaryGS10
10850010429189Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010429182008500104291828500104291820850010429182
1085001042918910850010429189

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid wax guardA device intended to shield the sound outlet of a hearing aid receiver (speaker) to prevent debris (e.g., wax, sweat) from entering. It typically consists of a plastic or metal perforated cover or gauze that may be changed periodically. Attachment and removal device may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(650)793-3008joshua.aguilar@eargo.com
1 (855) 690-9360info@eargo.com

Regulatory Flags#

DUNS number
079865289
Device count
6
DM exempt
true
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
00850010429779Eargo SE99-0198-0012025-10-22
00850010429786Eargo 899-0179-001-U2026-04-20
00850010429847Eargo SE99-0201-0012026-04-20
00850010429540Eargo 899-0181-0012025-05-13
00850010429793Eargo 899-0193-0012025-05-13
00850010429205Eargo RX99-0177-0012024-06-17
00850010429403Eargo 799-0156-0012023-03-20
00850010429304Eargo 899-0179-0012025-05-13
00850010429328Eargo 899-0180-0012025-05-13
00850010429687Eargo 899-0182-0012025-05-13
00850010429694Eargo 899-0184-0012025-05-13
00850010429700Eargo 899-0185-0012025-05-13
00850010429717Eargo 899-0186-0012025-05-13
00850010429724Eargo 899-0187-0012025-05-13
00850010429809Eargo 899-0196-0012025-05-13
00850010429816Eargo SE99-0197-0012025-04-07
00850010429731Eargo SE99-0188-0012025-04-03
00850010429748Eargo SE99-0189-0012025-04-03
00850010429755Eargo SE99-0190-0012025-04-03
00850010429762Eargo SE99-0191-0012025-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613389772838ampli-mini I 3 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772845ampli-mini I 2 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772920MEMINI I 4 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772937MEMINI I 3 5P CIC-10 NWL PHSonova AGESD2024-11-12
EDET038421luxaprint 3D shell white 500gDETAX GmbHESD2024-08-28
06945936704070NanoXiamen New Sound Technology Co., Ltd.ESD2024-05-21
06945936704087NanoXiamen New Sound Technology Co., Ltd.ESD2024-05-21
16945936703773NewsoundXiamen New Sound Technology Co., Ltd.ESD2024-01-19
06945936703776NewsoundXiamen New Sound Technology Co., Ltd.ESD2024-01-19
00810126190000AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190017AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190024AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190031AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190048AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190055AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190062AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190079AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190086AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190093AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190109AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190116AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190123AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190130AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190147AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190154AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190161AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190178AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190185AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190192AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190208AudinaAudina Hearing Instruments, Inc.ESD2023-01-26