swiftPro Cradle SWF-CRA01

GUDID 05060652910084

The swiftPro Cradle is the stand for the swiftPro Hand-Held Microwave Generator when not in use.

EMBLATION LIMITED

Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system Microwave hyperthermia system
Primary Device ID05060652910084
NIH Device Record Keyee239072-9741-44eb-92b1-a04d7d73f5a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameswiftPro Cradle
Version Model NumberSWF-CRA01
Catalog NumberSWF-CRA01
Company DUNS211334261
Company NameEMBLATION LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105060652910084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEYSystem, Ablation, Microwave And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-12
Device Publish Date2023-12-04

Devices Manufactured by EMBLATION LIMITED

05060652910053 - swiftPro System2023-12-12 swiftPro System
05060652910060 - swiftPro Hand-Held Microwave Generator2023-12-12 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 adaptor2023-12-12 The swiftPro DC power adaptor is used to power the swiftPro hand-held generator
05060652910084 - swiftPro Cradle2023-12-12The swiftPro Cradle is the stand for the swiftPro Hand-Held Microwave Generator when not in use.
05060652910084 - swiftPro Cradle2023-12-12 The swiftPro Cradle is the stand for the swiftPro Hand-Held Microwave Generator when not in use.
05060652910091 - swiftPro URT Applicator Tip2023-12-12 The swiftPro URT applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handp
05060652910107 - swiftPro URT Applicator Tip2023-12-12 Box of Ten swiftPro URT Applicator Tips
05060652910114 - swiftPro LRT Applicator Tip2023-12-12 The swiftPro LRT applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handp
05060652910121 - swiftPro LRT Applicator Tip2023-12-12 Box of Ten swiftPro LRT Applicator Tips

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