SOFT LINE LATERAL HEEL SUPPORT SM

GUDID 00610570105878

Bird & Cronin, LLC

Foot orthosis
Primary Device ID00610570105878
NIH Device Record Keyca8ec2d0-5cb3-4850-8d22-cd5bf1539a84
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOFT LINE LATERAL HEEL SUPPORT SM
Version Model Number50000972
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
GS100610570105878 [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 Date2022-08-29
Device Publish Date2022-08-20

On-Brand Devices [SOFT LINE LATERAL HEEL SUPPORT SM]

0061057010587850000972
0061057007617808140972

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