Henry Schein

Primary DI
H65857008765
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5700876
Catalog number
5700876
Device description
Glove 8.5 Pack
Published
2018-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PXDPrep kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXDPrep KitGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H65857008765PackageHIBCC10In Commercial Distribution
H65857008761PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/examination garment kitA collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840365903055InvenioGri-Alleset, Inc.PXD2025-03-12
10840365903052InvenioGRI Medical & Electronic Technology Co., Ltd.PXD2025-03-12
10304040167721Henry ScheinHENRY SCHEIN, INC.PXD2023-07-30
10304040167943Henry ScheinHENRY SCHEIN, INC.PXD2023-07-30
00304040167724Henry ScheinHENRY SCHEIN, INC.PXD2023-07-30
00304040167946Henry ScheinHENRY SCHEIN, INC.PXD2023-07-30
00883873772676Emergency Response KitPHYSIO-CONTROL, INC.PXD2023-03-12
M752UPC502L0Stradis Medical, LLC.STRADIS MEDICAL LLCPXD2020-06-19
M752UPC502M0Stradis Medical, LLC.STRADIS MEDICAL LLCPXD2020-06-19
M752UPC502L5Stradis Medical, LLC.STRADIS MEDICAL LLCPXD2020-06-19
M752UPC502M5Stradis Medical, LLC.STRADIS MEDICAL LLCPXD2020-06-19
H65857008711Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008721Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008731Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008741Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008751Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008761Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008715Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008725Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008735Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008745Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09
H65857008755Henry ScheinHENRY SCHEIN, INC.PXD2018-03-09