Heyman-capsule, 8mm diameter x 17.5mm length, with mandrin for 320 mm needles GM11005040

GUDID 00816389023413

Varian Medical Systems Deutschland GmbH

Cervical/intrauterine brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00816389023413
• NIH Device Record Key: c1aca8b6-ec2e-4007-8f3d-09e30d5e6d27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heyman-capsule, 8mm diameter x 17.5mm length, with mandrin for 320 mm needles
• Version Model Number: GM11005040
• Catalog Number: GM11005040
• 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: 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

• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816389023413 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160045
• Premarket Notification: K983436

FDA Product Code

• JAQ: System, applicator, radionuclide, remote-controlled

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00816389023413]

Moist Heat or Steam Sterilization

[00816389023413]

Moist Heat or Steam Sterilization

[00816389023413]

Moist Heat or Steam Sterilization

[00816389023413]

Moist Heat or Steam Sterilization

[00816389023413]

Moist Heat or Steam Sterilization

[00816389023413]

Moist Heat or Steam Sterilization

[00816389023413]

Moist Heat or Steam Sterilization

[00816389023413]

Moist Heat or Steam Sterilization

[00816389023413]

Moist Heat or Steam Sterilization

[00816389023413]

Moist Heat or Steam Sterilization

[00816389023413]

Moist Heat or Steam Sterilization

[00816389023413]

Moist Heat or Steam Sterilization

[00816389023413]

Moist Heat or Steam Sterilization

[00816389023413]

Moist Heat or Steam Sterilization

[00816389023413]

Moist Heat or Steam Sterilization

[00816389023413]

Moist Heat or Steam Sterilization

[00816389023413]

Moist Heat or Steam Sterilization

[00816389023413]

Moist Heat or Steam Sterilization

[00816389023413]

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: 2016-09-23

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• 10816389027180 - Protection caps, blue (pack of 20): 2024-05-03
• 10816389027210 - Sterilization plug, black (pack of 25): 2024-05-03