Length cutting gauge, 320mm for implant tubes and breast applicators up to 6 Fr. GM11010040

GUDID 00816389025189

Varian Medical Systems Deutschland GmbH

General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389025189
• NIH Device Record Key: fcb611f6-307a-4243-a3e2-0867a285c659
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Length cutting gauge, 320mm for implant tubes and breast applicators up to 6 Fr.
• Version Model Number: GM11010040
• Catalog Number: GM11010040
• 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: 320 Millimeter
• Length: 320 Millimeter
• Length: 320 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816389025189 [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

[00816389025189]

Moist Heat or Steam Sterilization

[00816389025189]

Moist Heat or Steam Sterilization

[00816389025189]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-23

On-Brand Devices [Length cutting gauge, 320mm for implant tubes and breast applicators up to 6 Fr.]

• 00816389025189: GM11010040
• 00816389029101: GM11010040