swiftPro LRT Applicator Tip SWF-AT03

GUDID 05060652910114

The swiftPro LRT applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handpiece.

EMBLATION LIMITED

Intraoperative gamma radiation detection system probe cover

• Primary Device ID: 05060652910114
• NIH Device Record Key: 89d817e4-e455-4b86-8bdb-9700c232f54e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: swiftPro LRT Applicator Tip
• Version Model Number: SWF-AT03
• Catalog Number: SWF-AT03
• Company DUNS: 211334261
• Company Name: EMBLATION LIMITED
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060652910114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222388

FDA Product Code

• NEY: System, Ablation, Microwave And Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-12
• Device Publish Date: 2023-12-04

On-Brand Devices [swiftPro LRT Applicator Tip]

• 05060652910121: Box of Ten swiftPro LRT Applicator Tips
• 05060652910114: The swiftPro LRT applicator tip is provided as a single-use, non-sterile disposable tip, which i