X-ray marker BV set II, up to 500 mm tubes, coded 07-12 GM11009680

GUDID 00816389024946

Varian Medical Systems Deutschland GmbH

Brachytherapy system remote afterloading source transfer tube Brachytherapy system remote afterloading source transfer tube Brachytherapy system remote afterloading source transfer tube

Primary Device ID	00816389024946
NIH Device Record Key	e036483f-fa08-4e95-bfe1-cf0db95f4366
Commercial Distribution Status	In Commercial Distribution
Brand Name	X-ray marker BV set II, up to 500 mm tubes, coded 07-12
Version Model Number	GM11009680
Catalog Number	GM11009680
Company DUNS	332474605
Company Name	Varian Medical Systems Deutschland GmbH
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	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 Dimensions

Length	500 Millimeter
Length	500 Millimeter
Length	500 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816389024946 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K983436

FDA Product Code

JAQ	System, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00816389024946]

Moist Heat or Steam Sterilization

[00816389024946]

Moist Heat or Steam Sterilization

[00816389024946]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-09-23

On-Brand Devices [X-ray marker BV set II, up to 500 mm tubes, coded 07-12]

00816389024946	GM11009680
00816389029194	GM11009680