Bailey Versatile Insole Small (Size 3- 5)

GUDID 05060418836146

BAILEY INSTRUMENTS LTD

Orthotic insole, prefabricated, non-antimicrobial
Primary Device ID05060418836146
NIH Device Record Keyced521a2-e294-4d23-8685-09a9cb351095
Commercial Distribution StatusIn Commercial Distribution
Brand NameBailey Versatile Insole Small (Size 3- 5)
Version Model NumberVER-A
Company DUNS769260357
Company NameBAILEY INSTRUMENTS LTD
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105060418836146 [Primary]

FDA Product Code

KNPOrthosis, Corrective Shoe

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-31
Device Publish Date2024-01-23

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