FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040137489
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5702171
Catalog number
5702171
Device description
Drape Lithotomy SFS Pack1
Published
2023-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PPFUrinary irrigation kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPFUrinary Irrigation KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040137489PrimaryGS10
00304040137482Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404013748910304040137489
00304040137482003040401374823040401374820304040137482

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Regulatory Flags#

DUNS number
012430880
Device count
12
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040194416Henry Schein570572557057252026-07-20
00304040194423Henry Schein570572757057272026-07-20
00304040194430Henry Schein570572857057282026-07-20
00304040194447Henry Schein570572957057292026-07-20
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25
10304040194055Essentials570567557056752026-06-25
10304040194062Essentials570567657056762026-06-25
10304040194079Essentials570567757056772026-06-25
10304040194086Essentials570567857056782026-06-25
00304040007426Henry Schein101700410170042016-09-24
00304040007433Henry Schein900417190041712016-09-24
00304040007440Henry Schein101562310156232016-09-24
00304040007457Henry Schein101562410156242016-09-24
00304040007464Henry Schein900419290041922016-09-24
00304040007471Henry Schein900419390041932016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918158259InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-04-26
16931918129235InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
16931918133737InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
16931918154916InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
16931918159546InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
16931918166513InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
16931918186344InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
16931918189604InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
16931918196305InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
26931918129232InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
26931918133734InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
26931918154913InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
26931918159543InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
26931918166510InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
26931918186341InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
26931918189601InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
26931918196302InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-17
16931918133799InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-02
16931918139814InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-02
16931918144603InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-02
16931918186696InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-02
26931918133796InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-02
26931918139811InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-02
26931918144600InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-02
26931918186693InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2024-02-02
16931918124025InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2023-10-27
16931918169255InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2023-10-27
26931918124022InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2023-10-27
26931918169252InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2023-10-27
16931918149646InvenioGRI Medical & Electronic Technology Co., Ltd.PPF2023-10-20