Universal Endometrial Applicator Set GM11009840

GUDID 00816389025035

Varian Medical Systems Deutschland GmbH

Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading

Primary Device ID	00816389025035
NIH Device Record Key	478d13f1-8a6e-45cd-bf3d-45cff407cdbc
Commercial Distribution Status	In Commercial Distribution
Brand Name	Universal Endometrial Applicator Set
Version Model Number	GM11009840
Catalog Number	GM11009840
Company DUNS	332474605
Company Name	Varian Medical Systems Deutschland GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	true
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 Identifiers

Device Issuing Agency	Device ID
GS1	00816389025035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K980576

FDA Product Code

JAQ	System, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00816389025035]

Moist Heat or Steam Sterilization

[00816389025035]

Moist Heat or Steam Sterilization

[00816389025035]

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	2016-09-19

On-Brand Devices [Universal Endometrial Applicator Set]

00816389025035	GM11009840
00810563022100	GM11009840