SOFT LINE FULL INSOLE XL

GUDID 00610570086719

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 Foot orthosis
Primary Device ID00610570086719
NIH Device Record Key21a7bba4-a5d9-4cd9-b286-67e0c9818f97
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOFT LINE FULL INSOLE XL
Version Model Number08140855
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
GS100610570086719 [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

On-Brand Devices [SOFT LINE FULL INSOLE XL]

0061057014486050000855
0061057008671908140855

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