AccessGUDID - DEVICE: Swift Applicator Handpiece (05060652910022)

GUDID

Device Identifier (DI) Information

Brand Name: Swift Applicator Handpiece
Version or Model: SWF-HP01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SWF-HP01
Company Name: EMBLATION LIMITED

Primary DI Number: 05060652910022
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 211334261 *Terms of Use

Device Description: The Swift® applicator handpiece connects to the Swift® microwave generator via the Swift® interconnect cable.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40791	Microwave hyperthermia system applicator, extracorporeal	A component of a microwave hyperthermia system designed to direct and deliver microwave energy used to produce a systemic or local heating effect. It is typically mounted on a floor, wall, or ceiling suspension that allows the operator to position the microwave source from a point outside the patient's body. The applicator assembly includes cables and connectors that interface with the energy-generating unit of the hyperthermia system during treatments. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NEY	System, Ablation, Microwave And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181941	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6c5dc960-842a-4bcd-98c5-e61225608506
Public Version Date: February 04, 2019
Public Version Number: 1
DI Record Publish Date: January 02, 2019