FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040081129
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5701028
Catalog number
5701028
Device description
Surgical Shoe Womans LG
Published
2019-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
ITWJOINT, ANKLE, EXTERNAL BRACE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITWJoint, Ankle, External BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040081129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040081129003040400811293040400811290304040081129

GMDN Terms#

Term, Definition table
TermDefinition
Foot orthosis, post-treatmentA specially designed shoe insert used to provide rigid or semi-rigid correction of the foot after an orthopaedic procedure. It is only for use during the finite period of treatment. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
1
DM exempt
true
Premarket exempt
true
Kit
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
00810178885398CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885404CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885411CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885428CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885435CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885442CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885459CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885466CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885473CoreTechVIVE HEALTH LLCITW2026-05-05
00810178885480CoreTechVIVE HEALTH LLCITW2026-05-05
00810178886135ViveVIVE HEALTH LLCITW2026-05-05
00749756880169DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756880183DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888127DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888134DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888141DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00749756888158DeRoyalDEROYAL INDUSTRIES, INC.ITW2026-04-02
00810113683898FlexSafe Ankle Recovery Orthosis, LargeManamed, Inc.ITW2025-10-31
00810113683904FlexSafe Ankle Recovery Orthosis, MediumManamed, Inc.ITW2025-10-31
00810113683911FlexSafe Ankle Recovery Orthosis, SmallManamed, Inc.ITW2025-10-31
00810113683928FlexSafe Ankle Recovery Orthosis, Extra LargeManamed, Inc.ITW2025-10-31
00810113683935FlexSafe Ankle Recovery Orthosis, Extra Small Manamed, Inc.ITW2025-10-31
00810113579801ViveVIVE HEALTH LLCITW2025-05-20
00810113579818ViveVIVE HEALTH LLCITW2025-05-20
00810113579825ViveVIVE HEALTH LLCITW2025-05-20
00810113579832ViveVIVE HEALTH LLCITW2025-05-20
00810113579849ViveVIVE HEALTH LLCITW2025-05-20
00810113579429CoreTechVIVE HEALTH LLCITW2024-10-24
00810113579436CoreTechVIVE HEALTH LLCITW2024-10-24
00810113579443CoreTechVIVE HEALTH LLCITW2024-10-24