SPRINT ANKLE REHAB KIT REG

GUDID 00610570087402

Bird & Cronin, LLC

Ankle/foot orthosis
Primary Device ID00610570087402
NIH Device Record Key568a2a86-8187-4125-a775-451e083aa5dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPRINT ANKLE REHAB KIT REG
Version Model Number08140644
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
GS100610570087402 [Primary]

FDA Product Code

ITWJoint, Ankle, External Brace

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

Devices Manufactured by Bird & Cronin, LLC

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00610570191406 - B-Cool Chest & AB Binder Wrap2023-05-31
00610570191413 - B-Cool Chest & AB Binder Wrap2023-05-31
50610570191418 - B-Cool Chest & AB Binder Wrap2023-05-31
00610570191451 - B-Cool Super Sling Plus Universal (Complete Set)2023-02-28
00610570191581 - Short Anklizer Low Profile Walker XS2023-02-28
00610570191598 - Short Anklizer Low Profile Walker Small2023-02-28
00610570191604 - Short Anklizer Low Profile Walker Medium2023-02-28

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