Therastep Gel Dots/Strips

Primary DI
00614464070129
Brand
Therastep Gel Dots/Strips
Company
Silipos Holding LLC
Model
7012
Published
2022-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KYSInsoles, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYSInsoles, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614464070129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614464070129006144640701296144640701290614464070129

GMDN Terms#

Term, Definition table
TermDefinition
Foot friction/impact protectorA device designed to be worn over/on the foot, often while wearing shoes, to provide a cushion to protect the whole foot or parts of the foot (e.g., toes, metatarsal heads, heel) from friction against surfaces or knocks against objects, to relieve pain during walking, and/or to prevent formation of hard areas and callouses. It is typically made of soft-padded or gel materials in a variety of forms (e.g., strip, pad, elastic band, digital tube), and some types may be inflatable or held in place with bands or straps around the foot. It is not specifically designed to protect a bunion. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
056112948
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00614464141157Post Operative Carpal Sleeve, Small, Left141152022-08-05
00614464141256Post Operative Carpal Sleeve, Small Right141252022-08-05
00614464141355Post Operative Carpal Sleeve, Large, Left141352022-08-05
00614464141454Post Operative Carpal Sleeve, Large, Right141452022-08-05
00614464141652Carpal Sleeve with 2 Thumb Holes141652022-08-05
00614464142055Carpal Pads With Pres. Sens.142052022-08-05
00614464341656Carpal Sleeve with 2 Thumb Holes - Bulk341652022-08-05
00614464928956Foam Toe Separator (Sheet of 12), Small, 1sheet/bag928952022-08-05
00614464928963Foam Toe Separator (Sheet of 12), Medium, 1sheet/bag928962022-08-05
00614464928970Foam Toe Separator (Sheet of 12), Large, 1sheet/bag928972022-08-05
00614464928987Foam Toe Separator (Sheet of 12), X-Large, 1sheet/bag928982022-08-05
00614464928994"""Deluxe Suede Hammer Toe Crest, Small, Left, 3pcs/bag """928992022-08-05
00614464929007"""Deluxe Suede Hammer Toe Crest, Small, Right, 3pcs/bag """929002022-08-05
00614464929014"""Deluxe Suede Hammer Toe Crest, Medium, Left, 3pcs/bag """929012022-08-05
00614464929021"""Deluxe Suede Hammer Toe Crest, Medium, Right, 3pcs/bag """929022022-08-05
00614464929038"""Deluxe Suede Hammer Toe Crest, Large, Left, 3pcs/bag """929032022-08-05
00614464929045"""Deluxe Suede Hammer Toe Crest, Large, Right, 3pcs/bag """929042022-08-05
00614464929052"""Felt Hammer Toe Crest, Small, Left, 3pcs/bag """929052022-08-05
00614464929069"""Felt Hammer Toe Crest, Small, Right, 3pcs/bag """929062022-08-05
00614464929076"""Felt Hammer Toe Crest, Medium, Left, 3pcs/bag """929072022-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04744946011787ESTCARBON Erismet OUKYS2024-10-29
04744946011794ESTCARBON Erismet OUKYS2024-10-29
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04744946011817ESTCARBON Erismet OUKYS2024-10-29
04744946011824ESTCARBON Erismet OUKYS2024-10-29
04744946011831ESTCARBON Erismet OUKYS2024-10-29
04744946011848ESTCARBON Erismet OUKYS2024-10-29
04744946011923ESTCARBON Erismet OUKYS2024-10-29
04744946011770ESTCARBON Erismet OUKYS2024-10-28
04744946011749ESTCARBON Erismet OUKYS2024-09-20
04744946011756ESTCARBON Erismet OUKYS2024-09-20
04744946011763ESTCARBON Erismet OUKYS2024-09-20
04744946010094ESTCARBON Erismet OUKYS2024-09-09
04744946010100ESTCARBON Erismet OUKYS2024-09-09
04744946010209ESTCARBON Erismet OUKYS2024-09-09
04744946010308ESTCARBON Erismet OUKYS2024-09-09
04744946011886ESTCARBON Erismet OUKYS2024-09-09
04744946011893ESTCARBON Erismet OUKYS2024-09-09
04744946011909ESTCARBON Erismet OUKYS2024-09-09
04744946011930ESTCARBON Erismet OUKYS2024-09-09
04744946011947ESTCARBON Erismet OUKYS2024-09-09
04744946011954ESTCARBON Erismet OUKYS2024-09-09
04744946011961ESTCARBON Erismet OUKYS2024-09-09
04744946011978ESTCARBON Erismet OUKYS2024-09-09
04744946012111ESTCARBON Erismet OUKYS2024-09-09
04744946012128ESTCARBON Erismet OUKYS2024-09-09
04744946012135ESTCARBON Erismet OUKYS2024-09-09
04744946012142ESTCARBON Erismet OUKYS2024-09-09
04744946012159ESTCARBON Erismet OUKYS2024-09-09
04744946012166ESTCARBON Erismet OUKYS2024-09-09