POST-OP SHOE DLX 1 MALE LG

GUDID 00610570078899

Bird & Cronin, LLC

Foot orthosis
Primary Device ID00610570078899
NIH Device Record Key61610a3a-2eef-41b4-8be6-4ce3bbdf3832
Commercial Distribution StatusIn Commercial Distribution
Brand NamePOST-OP SHOE DLX 1 MALE LG
Version Model Number08143274
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
GS100610570078899 [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 [POST-OP SHOE DLX 1 MALE LG]

0061057013793050003274
0061057007889908143274

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