BRAVOS Afterloader System VG15001002

GUDID 00816389029200

Varian Medical Systems Deutschland GmbH

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Primary Device ID	00816389029200
NIH Device Record Key	2f3b4bbc-4fba-491c-b7da-f9f346b25d76
Commercial Distribution Status	In Commercial Distribution
Brand Name	BRAVOS Afterloader System
Version Model Number	1.2
Catalog Number	VG15001002
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	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	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816389029200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K221797

FDA Product Code

JAQ	System, applicator, radionuclide, remote-controlled

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	2022-10-03
Device Publish Date	2022-09-23

On-Brand Devices [BRAVOS Afterloader System]

00816389027947	Bravos Afterloader System
00816389029200	1.2