AccessGUDID - DEVICE: NES Reprocessed Varicose Vein RF Catheter (B227RCF771000)

GUDID

Device Identifier (DI) Information

Brand Name: NES Reprocessed Varicose Vein RF Catheter
Version or Model: CF7-7-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: R-CF7-7-100
Company Name: NORTH EAST SCIENTIFIC INC

Primary DI Number: B227RCF771000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 608625823 *Terms of Use

Device Description: The NES Reprocessed Varicose Vein RF Catheter (Covidien Closurefast CF7-7-100) is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -29 and 60 Degrees Celsius
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Heating Element Diameter: 0.225 Centimeter
Device Size Text, specify: Heating Element Size: 7 Centimeter
Length: 100 Centimeter
Catheter Gauge: 7 French

Device Record Status

Public Device Record Key: bf34ec93-37e2-4453-b731-c0eb32c44caa
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 29, 2016