Spirotome Cervicore SS10CE

GUDID 05407005000175

The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissu

Bioncise

Soft-tissue biopsy needle, single-use

• Primary Device ID: 05407005000175
• NIH Device Record Key: 951900d9-96f1-4e16-be71-e2e9dfb47375
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spirotome Cervicore
• Version Model Number: SS10CE
• Catalog Number: SS10CE
• Company DUNS: 371402316
• Company Name: Bioncise
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05407005000175 [Package]; Contains: 05407005001172; Package: Box [5 Units]; In Commercial Distribution
GS1	05407005001172 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080095

FDA Product Code

• KNW: Instrument, Biopsy

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-01
• Device Publish Date: 2018-08-31

On-Brand Devices [Spirotome Cervicore]

• 05407005000182: The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use
• 05407005000175: The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be use