FDA.reportPublic FDA data

Foam Eartip 3C (Jumbo)

Primary DI
05713315009334
Brand
Foam Eartip 3C (Jumbo)
Company
NATUS MANUFACTURING LIMITED
Model
80A4821100
Catalog number
80A4821100
Published
2022-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ETTCushion, Earphone (For Audiometric Testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETTCushion, Earphone (For Audiometric Testing)Ear, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713315009334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315009334057133150093345713315009334

GMDN Terms#

Term, Definition table
TermDefinition
Audiometric ear tipA non-sterile luminal device intended to be connected to the distal end of an audiometric sound delivery tube and inserted into the ear canal, to allow test sounds to be delivered to the ear in isolation from background noise. It is designed to create a seal inside the ear canal whilst allowing the sound tube to pass through the lumen. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
896421240
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382830049405Natus9033B07212024-04-19
00382830049412Natus9033B07312024-04-19
00382830047722Natus 9031E27222020-07-08
00382830047746Keypoint9013L02419013L02412019-03-11
00382830049436Natus9033B07612024-04-19
00382830049078Keypoint9031E02239031E02232019-03-11
00382830050401Keypoint9031E02589031E02582019-03-13
00382830050418Keypoint9031E02779031E02772019-03-13
00382830050425Keypoint9031E04029031E04022019-03-13
00382830017237GrassF-E2-122016-08-25
00382830017244GrassF-E2-242016-08-25
00382830017251GrassF-E2-302016-08-25
00382830017268GrassF-E2-482016-08-25
00382830017275GrassF-E2-722016-08-25
00382830043601GrassF-E2-122016-08-25
00382830043618GrassF-E2-242016-08-25
00382830043625GrassF-E2-302016-08-25
05704736002868Dantec9013S00222016-08-25
05704736002875Dantec9013S00322016-08-25
05704736002882Dantec9013S00422016-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B43061000100GoCheck Audiometric Headphone AssemblyGobiquity, Inc.ETT2026-06-02
04260223146589Ear Tip ET-LT40G Pack/100 pcs.PATH medical GmbHETT2023-11-14
10840162500317Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500324Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500331Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500348Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500355Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500362Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500379Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500386Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500393Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500409Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500416Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500423Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500430Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500447Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500775Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500782Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500799Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500805Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500812Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500829Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500836Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500843Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500850Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500867Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500874Grason & Associates, LLCGrason & Associates LLCETT2022-11-11
10840162500164Grason & Associates, LLCGrason & Associates LLCETT2022-11-10
10840162500171Grason & Associates, LLCGrason & Associates LLCETT2022-11-10
10840162500188Grason & Associates, LLCGrason & Associates LLCETT2022-11-10