SOFT LINE FULL INSOLE LG

GUDID 00610570144853

Bird & Cronin, LLC

Foot orthosis Foot orthosis Foot orthosis Foot orthosis Foot orthosis Foot orthosis Foot orthosis Foot orthosis Foot orthosis Foot orthosis Foot orthosis Foot orthosis Foot orthosis
Primary Device ID00610570144853
NIH Device Record Keyfd94bc31-f089-4bce-a4a0-f7f4064dca5a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOFT LINE FULL INSOLE LG
Version Model Number50000854
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
GS100610570144853 [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 FULL INSOLE LG]

0061057014485350000854
0061057008670208140854

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