AccessGUDID - DEVICE: swiftPro LRT Applicator Tip (05060652910114)

GUDID

Device Identifier (DI) Information

Brand Name: swiftPro LRT Applicator Tip
Version or Model: SWF-AT03
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SWF-AT03
Company Name: EMBLATION LIMITED

Primary DI Number: 05060652910114
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 211334261 *Terms of Use

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

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:	Yes
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?
65056	Intraoperative gamma radiation detection system probe cover	A polymer sheath designed to cover an intraoperative gamma radiation detection system probe (not included) to create a physical barrier between the patient and the probe. This is a single-use 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 [?]
K222388	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: 89d817e4-e455-4b86-8bdb-9700c232f54e
Public Version Date: December 12, 2023
Public Version Number: 1
DI Record Publish Date: December 04, 2023