AccessGUDID - DEVICE: NES Reprocessed RF Stylet (RFS) (B227RRFS2612)

GUDID

Device Identifier (DI) Information

Brand Name: NES Reprocessed RF Stylet (RFS)
Version or Model: R-RFS2-6-12
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: R-RFS2-6-12
Company Name: NORTH EAST SCIENTIFIC INC

Primary DI Number: B227RRFS2612
Issuing Agency: HIBCC
Commercial Distribution End Date: July 12, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 608625823 *Terms of Use

Device Description: The device is the Covidien ClosureRFS Endovenous Radiofrequency (RF) Stylet that is reprocessed by Northeast Scientific, Inc.

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?
40794	Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal	A component of a radio-frequency (RF) hyperthermia system designed to be placed in the body to deliver radio-frequency (RF) energy to produce a systemic or local heating effect for the treatment of malignant or benign tumours, or other disease conditions. It is also referred to as an interstitial applicator or probe and is typically a catheter-enclosed conductor of RF energy that is introduced into the body either manually or endoscopically. It typically includes a thermometry component that monitors the temperature of the probe during operation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NUJ	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173214	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: be683057-21e8-49d5-ac2e-786826c46418
Public Version Date: July 13, 2023
Public Version Number: 3
DI Record Publish Date: May 01, 2018