FDA.reportPublic FDA data

PremierPro

Primary DI
10818566010794
Brand
PremierPro
Company
SVS LLC
Model
7901
Catalog number
7901
Device description
Cane, Adjustable Round Handle 29" - 38"
Published
2020-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IPSCane

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPSCanePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818566010794PackageGS16In Commercial Distribution
00818566010797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081856601079410818566010794
00818566010797008185660107978185660107970818566010797

GMDN Terms#

Term, Definition table
TermDefinition
Single-base walking stickA rod, typically made of wood or metal, with one leg/foot and a handgrip or curved handle and without forearm support used to assist a person with a disability to maintain their balance and support their weight while walking. It may be of fixed or adjustable length, and collapsible or non-collapsible.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-531-7699info@s2s-global.com

Regulatory Flags#

DUNS number
831375089
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00811220035495PremierPro882088202024-10-28
00811220035518PremierPro882188212024-10-28
10811220035430PremierProD5061D50612024-03-08
10811220035447PremierProD5062D50622024-03-08
10811220035454PremierProD5063D50632024-03-08
10811220035461PremierProD5064D50642024-03-08
10811220035478PremierProD5065D50652024-03-08
00811220035143PremierProFL1003DFL1003D2024-02-14
00811220035174PremierProFL1005DFL1005D2024-02-14
00811220035099PremierProFL1010DFL1010D2024-02-14
00811220035112PremierProFL1010SFFL1010SF2024-02-14
00811220034412PremierPro™31T1417531T141752022-12-19
00811220034443PremierPro™31T1617731T161772022-12-19
00811220034474PremierPro™31T1811631T181162022-12-19
00811220034504PremierPro™31T1818831T181882022-12-19
00811220034535PremierPro™31T2011631T201162022-12-19
00811220034566PremierPro™31T2010031T201002022-12-19
00811220034597PremierPro™31T2018831T201882022-12-19
00811220034627PremierPro™31T2210031T221002022-12-19
00811220034658PremierPro™31T2407531T240752022-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810041984524Vive MobilityVIVE HEALTH LLCIPS2025-09-25
00810178884490Vive MobilityVIVE HEALTH LLCIPS2025-09-25
00818323025422Vive MobilityVIVE HEALTH LLCIPS2025-09-25
00815027012741DALTON QUAD CANEDALTON MEDICAL CORPORATIONIPS2025-09-18
06972223254390CaneFoshan Shunkangda Medical Tech Co.,LtdIPS2025-07-11
30023601017100CAREX HEALTH BRANDSCOMPASS HEALTH BRANDS CORP.IPS2025-05-21
00757183903078ComfytopiaComfytopia, Inc.IPS2025-02-23
00767674405899ComfytopiaComfytopia, Inc.IPS2025-02-23
00819567017396ComfytopiaComfytopia, Inc.IPS2025-02-23
00854194003015ComfytopiaComfytopia, Inc.IPS2025-02-23
30023601017926CAREX HEALTH BRANDSCOMPASS HEALTH BRANDS CORP.IPS2024-09-09
10810041983333ViveVIVE HEALTH LLCIPS2024-09-04
10850041211395VIVEVIVE HEALTH LLCIPS2024-07-17
10850041211401VIVEVIVE HEALTH LLCIPS2024-07-17
10850041211418VIVEVIVE HEALTH LLCIPS2024-07-17
10850041211432VIVEVIVE HEALTH LLCIPS2024-07-17
10810041981834VIVEVIVE HEALTH LLCIPS2024-05-03
10810113576746ViveVIVE HEALTH LLCIPS2024-05-03
10810113576166ViveVIVE HEALTH LLCIPS2024-03-08
10810113576173ViveVIVE HEALTH LLCIPS2024-03-08
10810113574254ViveVIVE HEALTH LLCIPS2024-01-05
10810113574261ViveVIVE HEALTH LLCIPS2024-01-05
10810113574346ViveVIVE HEALTH LLCIPS2024-01-05
10818323021247ViveVIVE HEALTH LLCIPS2023-11-13
10057475247345BIOS LivingThermor LtdIPS2023-09-15
10057475247352BIOS LivingThermor LtdIPS2023-09-15
10057475247680BIOS LivingThermor LtdIPS2023-09-15
10057475247758BIOS LivingThermor LtdIPS2023-09-15
10057475247765BIOS LivingThermor LtdIPS2023-09-15