Crook Prostate Template for 2.0 mm needles GM11012230

GUDID 00816389020245

B-K labelling, including locking collets (pack of 25) and needle collet wrench

Varian Medical Systems Deutschland GmbH

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• Primary Device ID: 00816389020245
• NIH Device Record Key: d5e06b1d-f498-41dd-82e8-a9ea7fe4e947
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Crook Prostate Template for 2.0 mm needles
• Version Model Number: GM11012230
• Catalog Number: GM11012230
• 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: 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	00816389020245 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232949

FDA Product Code

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

Sterilization

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

[00816389020245]

Moist Heat or Steam Sterilization

[00816389020245]

Moist Heat or Steam Sterilization

[00816389020245]

Moist Heat or Steam Sterilization

[00816389020245]

Moist Heat or Steam Sterilization

[00816389020245]

Moist Heat or Steam Sterilization

[00816389020245]

Moist Heat or Steam Sterilization

[00816389020245]

Moist Heat or Steam Sterilization

[00816389020245]

Moist Heat or Steam Sterilization

[00816389020245]

Moist Heat or Steam Sterilization

[00816389020245]

Moist Heat or Steam Sterilization

[00816389020245]

Moist Heat or Steam Sterilization

[00816389020245]

Moist Heat or Steam Sterilization

[00816389020245]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-27
• Device Publish Date: 2024-02-19

On-Brand Devices [Crook Prostate Template for 2.0 mm needles]

• 00816389020269: Siemens labelling, including locking collets (pack of 25) and needle collet wrench
• 00816389020245: B-K labelling, including locking collets (pack of 25) and needle collet wrench