FDA.reportPublic FDA data

Henry Schein

Primary DI
20304040029200
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1125528
Catalog number
1125528
Device description
Otoscope Disp Tips Ear Spec
Published
2018-12-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
ERAOTOSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERAOtoscopeEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20304040029200PackageGS124In Commercial Distribution
10304040029203PrimaryGS10
00304040029206Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404002920020304040029200
1030404002920310304040029203
00304040029206003040400292063040400292060304040029206

GMDN Terms#

Term, Definition table
TermDefinition
Ear speculum, single-useA semi-rigid or rigid, plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may be referred to as an ear cannula. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter4Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
1000
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
false
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
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00732094055245Welch Allyn, Inc.WELCH ALLYN, INC.ERA2026-03-06
40050428029495CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDERA2026-02-13
06972545090416JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-02-04
16972545090093JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-02-04
06974546524372TealmedNingbo Tealmed Emergency Products Co., Ltd.ERA2026-01-16
00850042909218ProsidioProsidio LLCERA2025-12-05
00850042909225ProsidioProsidio LLCERA2025-12-05
00850042909256ProsidioProsidio LLCERA2025-12-05
00850042909263ProsidioProsidio LLCERA2025-12-05
00850042909270ProsidioProsidio LLCERA2025-12-05
00850042909287ProsidioProsidio LLCERA2025-12-05
00850042909294ProsidioProsidio LLCERA2025-12-05
00850042909300ProsidioProsidio LLCERA2025-12-05
00850042909317ProsidioProsidio LLCERA2025-12-05
00850042909324ProsidioProsidio LLCERA2025-12-05
00850042909331ProsidioProsidio LLCERA2025-12-05
00850042909348ProsidioProsidio LLCERA2025-12-05
00850042909355ProsidioProsidio LLCERA2025-12-05
00850042909362ProsidioProsidio LLCERA2025-12-05
00850042909379ProsidioProsidio LLCERA2025-12-05
00850042909386ProsidioProsidio LLCERA2025-12-05
00850042909393ProsidioProsidio LLCERA2025-12-05
00850042909409ProsidioProsidio LLCERA2025-12-05
00850042909416ProsidioProsidio LLCERA2025-12-05
00850042909423ProsidioProsidio LLCERA2025-12-05
00850042909430ProsidioProsidio LLCERA2025-12-05
00850042909447ProsidioProsidio LLCERA2025-12-05
00850042909454ProsidioProsidio LLCERA2025-12-05
00850042909461ProsidioProsidio LLCERA2025-12-05
00850042909478ProsidioProsidio LLCERA2025-12-05