"Active Heel Cushions, Men's, 1 Pair"

GUDID 00614464072192

Silipos Holding LLC

Orthotic insole, prefabricated, antimicrobial
Primary Device ID00614464072192
NIH Device Record Key9d261f7b-e970-4600-a19d-681c70d0e485
Commercial Distribution StatusIn Commercial Distribution
Brand Name"Active Heel Cushions, Men's, 1 Pair"
Version Model Number7219
Company DUNS056112948
Company NameSilipos Holding LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100614464072192 [Primary]

FDA Product Code

KYSInsoles, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-01
Device Publish Date2022-08-24