DEVICE: NES Reprocessed Varicose Vein RF Catheter (B227RCF771000)

Device Identifier (DI) Information

NES Reprocessed Varicose Vein RF Catheter
CF7-7-100
In Commercial Distribution
R-CF7-7-100
NORTH EAST SCIENTIFIC INC
B227RCF771000
HIBCC

1
608625823 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

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

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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
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Device Record Status

bf34ec93-37e2-4453-b731-c0eb32c44caa
March 29, 2018
2
July 29, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
203-756-2111
info@smarthealth-care.com
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