FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040137366
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5702159
Catalog number
5702159
Device description
SFS Cystoscopy Pack 1
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
10304040137366PrimaryGS10
00304040137369Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404013736610304040137366
00304040137369003040401373693040401373690304040137369

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
8
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