LEVEL-RITE HEEL LIFT SM

GUDID 00610570073627

Bird & Cronin, LLC

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Primary Device ID	00610570073627
NIH Device Record Key	545827b8-00a3-417b-b6e8-fd3dfcb6003b
Commercial Distribution Status	In Commercial Distribution
Brand Name	LEVEL-RITE HEEL LIFT SM
Version Model Number	08140552
Company DUNS	045975349
Company Name	Bird & Cronin, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00610570073627 [Primary]

FDA Product Code

KNP	Orthosis, Corrective Shoe

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-09-07
Device Publish Date	2022-08-30

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00610570191413 - B-Cool Chest & AB Binder Wrap	2023-05-31
50610570191418 - B-Cool Chest & AB Binder Wrap	2023-05-31
00610570191451 - B-Cool Super Sling Plus Universal (Complete Set)	2023-02-28
00610570191581 - Short Anklizer Low Profile Walker XS	2023-02-28
00610570191598 - Short Anklizer Low Profile Walker Small	2023-02-28
00610570191604 - Short Anklizer Low Profile Walker Medium	2023-02-28