VOLLEY TENNIS ELBOW UNIV. 6/BOX

GUDID 00610570024063

Bird & Cronin, LLC

Elbow orthosis Elbow orthosis Elbow orthosis Elbow orthosis Elbow orthosis Elbow orthosis Elbow orthosis Elbow orthosis Elbow orthosis Elbow orthosis Elbow orthosis Elbow orthosis Elbow orthosis Elbow orthosis

Primary Device ID	00610570024063
NIH Device Record Key	e2c708eb-8c5f-4bce-9670-2c6e623957af
Commercial Distribution Status	In Commercial Distribution
Brand Name	VOLLEY TENNIS ELBOW UNIV. 6/BOX
Version Model Number	08147430
Company DUNS	045975349
Company Name	Bird & Cronin, LLC
Device Count	6
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	00610570024063 [Primary]
GS1	00610570189700 [Unit of Use]

FDA Product Code

IQI	Orthosis, Limb Brace

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

Devices Manufactured by Bird & Cronin, LLC

00610570191390 - B-Cool Chest & AB Binder Wrap	2023-05-31
00610570191406 - B-Cool Chest & AB Binder Wrap	2023-05-31
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