Breast Imaging Accessory

GUDID 00850816007195

Radiological breast positioner, non-wearable

Primary Device ID	00850816007195
NIH Device Record Key	2d4830f0-1a5f-4a65-88ab-7f7d12778d1f
Commercial Distribution Status	In Commercial Distribution
Brand Name	Breast Imaging Accessory
Version Model Number	BIA
Company DUNS	148548738
Company Name	DIGIRAD CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Phone	8587261600
Email	callcenter@digirad.com

Device Issuing Agency	Device ID
GS1	00850816007195 [Primary]

IYX	Camera, Scintillation (Gamma)

Steralize Prior To Use	false
Device Is Sterile	false