Swift® Applicator Tips SWF-AT01-10

GUDID 05060652910046

Box of Ten Swift® applicator tips. Swift® applicator tip is provided as a single use, non-sterile disposable tip, which is connected to the Swift® ha

EMBLATION LIMITED

Medical equipment handle cover, single-use, non-sterile Intraoperative gamma radiation detection system probe cover Intraoperative gamma radiation detection system probe cover Intraoperative gamma radiation detection system probe cover Intraoperative gamma radiation detection system probe cover Intraoperative gamma radiation detection system probe cover Intraoperative gamma radiation detection system probe cover Intraoperative gamma radiation detection system probe cover Intraoperative gamma radiation detection system probe cover Intraoperative gamma radiation detection system probe cover Intraoperative gamma radiation detection system probe cover Intraoperative gamma radiation detection system probe cover Intraoperative gamma radiation detection system probe cover Intraoperative gamma radiation detection system probe cover Intraoperative gamma radiation detection system probe cover Intraoperative gamma radiation detection system probe cover Intraoperative gamma radiation detection system probe cover Intraoperative gamma radiation detection system probe cover

• Primary Device ID: 05060652910046
• NIH Device Record Key: 3fafe807-7f97-4c05-bdf3-88f2b085ed03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Swift® Applicator Tips
• Version Model Number: SWF-AT01-10
• Catalog Number: SWF-AT01-10
• 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	05060652910046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181941

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: 2019-02-18
• Device Publish Date: 2019-01-17

Devices Manufactured by EMBLATION LIMITED

• 05060652910138 - swiftPro Battery Pack: 2024-07-04 The battery pack for the swiftPro Hand-held Microwave Generator
• 05060652910145 - swiftPro Charging Dock: 2024-07-04 The swiftPro Charging dock
• 05060652910152 - swiftPro Battery Power System: 2024-07-04 swiftPro Battery Power System
• 05060652910053 - swiftPro System: 2023-12-12 swiftPro System
• 05060652910060 - swiftPro Hand-Held Microwave Generator: 2023-12-12 The swiftPro Hand-Held microwave generator is intended to be used with the swiftPro applicator tip for the coagulation of soft t
• 05060652910077 - swiftPro DC power adaptor: 2023-12-12 The swiftPro DC power adaptor is used to power the swiftPro hand-held generator
• 05060652910084 - swiftPro Cradle: 2023-12-12 The swiftPro Cradle is the stand for the swiftPro Hand-Held Microwave Generator when not in use.
• 05060652910091 - swiftPro URT Applicator Tip: 2023-12-12 The swiftPro URT applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handp