Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrin GM11014700

GUDID 10810563022022

Varian Medical Systems Deutschland GmbH

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Primary Device ID	10810563022022
NIH Device Record Key	53ea3669-25f4-4dc6-abd0-4a7eb6cceec4
Commercial Distribution Status	In Commercial Distribution
Brand Name	Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrin
Version Model Number	GM11014700
Catalog Number	GM11014700
Company DUNS	332474605
Company Name	Varian Medical Systems Deutschland GmbH
Device Count	1
DM Exempt	true
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	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	00810563022025 [Primary]
GS1	10810563022022 [Package] Contains: 00810563022025 Package: [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K141624

FDA Product Code

JAQ	System, applicator, radionuclide, remote-controlled