MR SBRT Bridge, Large RT-4800-B2

GUDID 10841962110980

MR SBRT Bridge, Large

Qfix

Indexed-immobilization patient positioning system

Primary Device ID	10841962110980
NIH Device Record Key	3d579210-941a-4a52-89a8-3445fa6ac57f
Commercial Distribution Status	In Commercial Distribution
Brand Name	MR SBRT Bridge, Large
Version Model Number	RT-4800-B2
Catalog Number	RT-4800-B2
Company DUNS	808875397
Company Name	Qfix
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Safe
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

Customer Support Contacts

Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com
Phone	610-268-0585
Email	Compliance@qfix.com

Device Dimensions

Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter
Width	60.7 Centimeter
Height	48 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841962110980 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K193243

FDA Product Code

IYE	Accelerator, Linear, Medical

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	2020-03-12
Device Publish Date	2020-03-04

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