POST-OP SHOE DLX 1 MALE XL

GUDID 00610570137947

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 ID00610570137947
NIH Device Record Key67200e8d-d9af-4ee5-bd01-0eb9ef11af49
Commercial Distribution StatusIn Commercial Distribution
Brand NamePOST-OP SHOE DLX 1 MALE XL
Version Model Number50003275
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
GS100610570137947 [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 [POST-OP SHOE DLX 1 MALE XL]

0061057013794750003275
0061057007890508143275

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