Stainless steel needle 250 mm, 18 gauge, trocar point, VariSource only GM11009570

GUDID 00816389024847

Varian Medical Systems Deutschland GmbH

Brachytherapy needle

• Primary Device ID: 00816389024847
• NIH Device Record Key: a6cc1e97-0d40-4eb7-8f6b-e6de2f0c83c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stainless steel needle 250 mm, 18 gauge, trocar point, VariSource only
• Version Model Number: GM11009570
• Catalog Number: GM11009570
• 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: 250 Millimeter
• Length: 250 Millimeter
• Length: 250 Millimeter
• Length: 250 Millimeter
• Length: 250 Millimeter
• Length: 250 Millimeter
• Length: 250 Millimeter
• Length: 250 Millimeter
• Length: 250 Millimeter
• Length: 250 Millimeter
• Length: 250 Millimeter
• Length: 250 Millimeter
• Length: 250 Millimeter
• Length: 250 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816389024847 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073133

FDA Product Code

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

Sterilization

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

[00816389024847]

Moist Heat or Steam Sterilization

[00816389024847]

Moist Heat or Steam Sterilization

[00816389024847]

Moist Heat or Steam Sterilization

[00816389024847]

Moist Heat or Steam Sterilization

[00816389024847]

Moist Heat or Steam Sterilization

[00816389024847]

Moist Heat or Steam Sterilization

[00816389024847]

Moist Heat or Steam Sterilization

[00816389024847]

Moist Heat or Steam Sterilization

[00816389024847]

Moist Heat or Steam Sterilization

[00816389024847]

Moist Heat or Steam Sterilization

[00816389024847]

Moist Heat or Steam Sterilization

[00816389024847]

Moist Heat or Steam Sterilization

[00816389024847]

Moist Heat or Steam Sterilization

[00816389024847]

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: 2016-09-22

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