SOFT LINE LATERAL HEEL SUPPORT LG

GUDID 00610570105892

Bird & Cronin, LLC

Foot orthosis
Primary Device ID00610570105892
NIH Device Record Key0d90d1c4-85a3-42a0-8c3b-deb22fce3f09
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOFT LINE LATERAL HEEL SUPPORT LG
Version Model Number50000974
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
GS100610570105892 [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 LG]

0061057010589250000974
0061057007619208140974

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.