Head Frame Cranial Screws - Long and Short

GUDID 10858086006280

Contains one 10858086006266 Cranial Screws, Long, Pouch of 2 and one 10858086006273 Cranial Screws, Short, Pouch of 2

VARIAN MEDICAL SYSTEMS, INC.

Stereotactic radiosurgical invasive head frame

• Primary Device ID: 10858086006280
• NIH Device Record Key: 483dc247-ca44-403f-8774-b4349cd3c6aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Head Frame Cranial Screws - Long and Short
• Version Model Number: P1006801006
• Company DUNS: 009120817
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	00858086006283 [Primary]
GS1	10858086006280 [Package]; Contains: 00858086006283; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180586

FDA Product Code

• IYE: Accelerator, linear, medical

Sterilization

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

[10858086006280]

Moist Heat or Steam Sterilization

[10858086006280]

Moist Heat or Steam Sterilization

[10858086006280]

Moist Heat or Steam Sterilization

[10858086006280]

Moist Heat or Steam Sterilization

[10858086006280]

Moist Heat or Steam Sterilization

[10858086006280]

Moist Heat or Steam Sterilization

[10858086006280]

Moist Heat or Steam Sterilization

[10858086006280]

Moist Heat or Steam Sterilization

[10858086006280]

Moist Heat or Steam Sterilization

[10858086006280]

Moist Heat or Steam Sterilization

[10858086006280]

Moist Heat or Steam Sterilization

[10858086006280]

Moist Heat or Steam Sterilization

[10858086006280]

Moist Heat or Steam Sterilization

[10858086006280]

Moist Heat or Steam Sterilization

[10858086006280]

Moist Heat or Steam Sterilization

[10858086006280]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-25
• Device Publish Date: 2021-01-16

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