FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040117856
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5701467
Catalog number
5701467
Device description
Aluminum crutches, adult Tall Medx
Published
2019-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IPRCRUTCH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPRCrutchPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040117856PackageGS18In Commercial Distribution
00304040117859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404011785610304040117856
00304040117859003040401178593040401178590304040117859

GMDN Terms#

Term, Definition table
TermDefinition
Axillary crutchA staff-like mobility aid used to assist a person with a disability to support their weight while walking. The device has one leg, a padded hand support at the level of the user's wrist, and an under-arm (the armpit or axilla) padded platform. The pads are typically made of non-slip material (e.g., rubber, glycerin gel, sheepskin). The device may be adjustable in length and is typically made of wood or metal [e.g., aluminium (Al), titanium (Ti)].

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975185620159BaichenNINGBO BAICHEN MEDICAL DEVICES CO., LTDIPR2026-01-07
06972223254703CrutchFoshan Shunkangda Medical Tech Co.,LtdIPR2025-07-17
06972223254710CrutchFoshan Shunkangda Medical Tech Co.,LtdIPR2025-07-17
06972223254727CrutchFoshan Shunkangda Medical Tech Co.,LtdIPR2025-07-17
06972223254734CrutchFoshan Shunkangda Medical Tech Co.,LtdIPR2025-07-17
06972223254697CrutchFoshan Shunkangda Medical Tech Co.,LtdIPR2025-07-11
06972855535065Adjustable Aluminum CrutchesJiangsu Jumao X-Care Medical Equipment Co.,LtdIPR2025-07-08
06950715505571cofoeCofoe Medical Technology Co.,LtdIPR2024-12-09
10850632007987True Comfort Quad CaneHOME AIDE DIAGNOSTICS, INC.IPR2024-10-08
10818323020448VIVEVIVE HEALTH LLCIPR2024-05-01
10860009370606Medzah Aluminum Crutches SmallMedzah IndustriesIPR2024-01-23
10860009370613Medzah Aluminum Crutches MediumMedzah IndustriesIPR2024-01-23
10860009370620Medzah Aluminum Crutches TallMedzah IndustriesIPR2024-01-23
10810113574810VIVEVIVE HEALTH LLCIPR2023-11-13
10810113574827VIVEVIVE HEALTH LLCIPR2023-11-13
06940979190033LUYAOZhejiang Luyao Electronics Technology Co., Ltd.IPR2023-08-29
10810113574025ViveVIVE HEALTH LLCIPR2023-08-23
10810113574032ViveVIVE HEALTH LLCIPR2023-08-23
10810113574049ViveVIVE HEALTH LLCIPR2023-08-23
10810113572809VIVEVIVE HEALTH LLCIPR2023-06-30
10810113572816VIVEVIVE HEALTH LLCIPR2023-06-30
10810132041546HCSConcordance Healthcare Solutions LLCIPR2023-06-23
10810132041553HCSConcordance Healthcare Solutions LLCIPR2023-06-23
10810132041560HCSConcordance Healthcare Solutions LLCIPR2023-06-23
10810132041577HCSConcordance Healthcare Solutions LLCIPR2023-06-23
00850051333042GAESCAMp2g Diagnostic CorpIPR2023-04-27
00850051333059GAESCAMp2g Diagnostic CorpIPR2023-04-27
00850051333066GAESCAMp2g Diagnostic CorpIPR2023-04-27
10057475060340BIOS LivingThermor LtdIPR2023-03-31
10057475060357BIOS LivingThermor LtdIPR2023-03-31