FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040165161
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5703106
Catalog number
5703106
Device description
Henry Schein Lubricating Jelly 4oz Tube
Published
2023-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true

Product Codes#

Code, Name table
CodeName
KMJLubricant, patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMJLubricant, PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040165161PrimaryGS10
00304040165164Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404016516110304040165161
00304040165164003040401651643040401651640304040165164

GMDN Terms#

Term, Definition table
TermDefinition
General-body orifice lubricantA substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
012430880
Device count
72
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040199602Henry Schein570599457059942026-10-01
00304040199619Henry Schein570599557059952026-10-01
00304040199626Henry Schein570599657059962026-10-01
00304040199633Henry Schein570599757059972026-10-01
00304040199640Henry Schein570599857059982026-10-01
00304040199657Henry Schein570599957059992026-10-01
00304040199664Henry Schein570600057060002026-10-01
00304040199671Henry Schein570600157060012026-10-01
00304040199312Henry Schein570597057059702026-09-30
00304040199091Henry Schein570594357059432026-09-29
00304040199107Henry Schein570594657059462026-09-29
00304040199114Henry Schein570594457059442026-09-29
00304040199121Henry Schein570594757059472026-09-29
00304040199138Henry Schein570594557059452026-09-29
00304040199145Henry Schein570594857059482026-09-29
00304040199152Henry Schein570594957059492026-09-29
00304040199169Henry Schein570595157059512026-09-29
00304040199176Henry Schein570595057059502026-09-29
00304040199183Henry Schein570595257059522026-09-29
00304040199190Henry Schein570595357059532026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902221596ARROWTELEFLEX INCORPORATEDKMJ2026-07-29
00692379000097Water-based Lubricant for UrestaResilia IncKMJ2026-07-03
08887500730017SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
08887500730024SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
08887500730031SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
00627987071429NixitMAYER LABORATORIES, INC.KMJ2025-09-16
06936603230992Medical LubricantYangzhou Fartley Medical Instrument Technology Co., LtdKMJ2025-06-23
16936603230999Medical LubricantYangzhou Fartley Medical Instrument Technology Co., LtdKMJ2025-06-23
30080196074192MEDLINEMEDLINE INDUSTRIES, INC.KMJ2025-04-25
40080196074199MEDLINEMEDLINE INDUSTRIES, INC.KMJ2025-04-25
17290100666156Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKMJ2025-04-02
00858276007557Sterile Bacteriostatic Lubricating GelMicro-tech UsaKMJ2025-03-05
00850025860482Endoscopy Kit - Basic + GownsMicro-tech UsaKMJ2025-03-04
10850025860489Endoscopy Kit - Basic + GownsMicro-tech UsaKMJ2025-03-04
00850025860062Endoscopy Kit - Basic+Micro-tech UsaKMJ2025-03-03
00850025860215Endoscopy Kit - Compliance+Micro-tech UsaKMJ2025-03-03
00850025860277Endoscopy Kit - ComplianceMicro-tech UsaKMJ2025-03-03
00858276007434Endoscopy Kit - BasicMicro-tech UsaKMJ2025-03-03
00858276007465Endoscopy Kit - UpperMicro-tech UsaKMJ2025-03-03
00858276007496Endoscopy Kit - Set UpMicro-tech UsaKMJ2025-03-03
00850025860079Endoscopy Kit - Basic+Micro-tech UsaKMJ2025-03-03
00850025860222Endoscopy Kit - Compliance+Micro-tech UsaKMJ2025-03-03
00850025860284Endoscopy Kit - ComplianceMicro-tech UsaKMJ2025-03-03
00858276007441Endoscopy Kit - BasicMicro-tech UsaKMJ2025-03-03
00858276007472Endoscopy Kit - UpperMicro-tech UsaKMJ2025-03-03
00858276007502Endoscopy Kit - Set UpMicro-tech UsaKMJ2025-03-03
00850041319001EsoCoolNuvaira, Inc.KMJ2025-01-29
00850041319018EsoCoolNuvaira, Inc.KMJ2025-01-29
00850058254623EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16
00850058254630EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16