TULI'S PRO HEEL CUP SM

GUDID 00610570079742

Bird & Cronin, LLC

Cast walking heel
Primary Device ID00610570079742
NIH Device Record Key58aa435d-c4f5-4a5f-96ff-a77c7a7953c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameTULI'S PRO HEEL CUP SM
Version Model Number08140426
Company DUNS045975349
Company NameBird & Cronin, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100610570079742 [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 Date2022-09-07
Device Publish Date2022-08-30