FDA.reportPublic FDA data

Henry Schein

Primary DI
H65857030875
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5703087
Catalog number
5703087
Device description
Pack Minor Set Up F/ DFW
Published
2022-05-25
Public version status
Update
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
PYBMinor surgical procedures tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYBMinor Surgical Procedures TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H65857030875PrimaryHIBCC0
H65857030871Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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
5
Premarket exempt
true
Kit
true
Lot or batch
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
00844107000736Arbutus MedicalArbutus Medical IncPYB2026-04-28
00844107000750Arbutus MedicalArbutus Medical IncPYB2026-04-28
00844107000781Arbutus MedicalArbutus Medical IncPYB2026-04-28
00844107000828Arbutus MedicalArbutus Medical IncPYB2026-04-28
00884450116913Merit Medical®Merit Medical Systems, Inc.PYB2025-09-09
00884450096529Merit Medical®Merit Medical Systems, Inc.PYB2025-07-01
00884450089897Merit Medical®Merit Medical Systems, Inc.PYB2025-05-20
00840365908623InvenioGri-Alleset, Inc.PYB2025-03-12
00884450185261Merit Medical®Merit Medical Systems, Inc.PYB2023-01-04
M7526821425R10STRADIS HEALTHCARESTRADIS MEDICAL, LLCPYB2022-12-22
10197106029916CARDINAL HEALTHCardinal Health 200, LLCPYB2022-11-18
H65857031545Henry ScheinHENRY SCHEIN, INC.PYB2022-08-25
00884450187494Merit Medical®Merit Medical Systems, Inc.PYB2021-10-28
00844107000637Arbutus MedicalArbutus Medical IncPYB2021-10-19
00884450186428Merit Medical®Merit Medical Systems, Inc.PYB2021-03-03
00884450248805Merit Medical®Merit Medical Systems, Inc.PYB2019-10-31
00884450055144PAL™Merit Medical Systems, Inc.PYB2018-09-17
00884450166062Merit Medical®Merit Medical Systems, Inc.PYB2018-09-17
00884450049556Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450049570Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450049587Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450049594Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450049617Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450053799Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450053805Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450053836Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450055120Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450055137Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450143865Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14
00884450144558Merit Medical®Merit Medical Systems, Inc.PYB2018-09-14