FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040137410
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5702164
Catalog number
5702164
Device description
SFS Cystoscopy Pack 4
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
10304040137410PrimaryGS10
00304040137413Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404013741010304040137410
00304040137413003040401374133040401374130304040137413

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
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

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