Plastic needle MR safe, 2.0 mm diameter x 320 mm length, with mandrin GM11014720

GUDID 30810563021975

Varian Medical Systems Deutschland GmbH

Brachytherapy needle

Primary Device ID	30810563021975
NIH Device Record Key	268fb39f-242a-42f7-bc78-c61867905351
Commercial Distribution Status	In Commercial Distribution
Brand Name	Plastic needle MR safe, 2.0 mm diameter x 320 mm length, with mandrin
Version Model Number	GM11014720
Catalog Number	GM11014720
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	00810563021974 [Primary]
GS1	10810563021971 [Package] Contains: 00810563021974 Package: [10 Units] In Commercial Distribution
GS1	20810563021978 [Package] Contains: 10810563021971 Package: [20 Units] In Commercial Distribution
GS1	30810563021975 [Package] Contains: 20810563021978 Package: [50 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K141624

FDA Product Code

JAQ	System, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

[30810563021975]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-02-26
Device Publish Date	2024-02-16

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