NES Reprocessed RF Stylet (RFS) R-RFS2-6-12

GUDID B227RRFS2612

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

NORTH EAST SCIENTIFIC INC

Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal
Primary Device IDB227RRFS2612
NIH Device Record Keybe683057-21e8-49d5-ac2e-786826c46418
Commercial Distribution Discontinuation2018-05-02
Commercial Distribution StatusNot in Commercial Distribution
Brand NameNES Reprocessed RF Stylet (RFS)
Version Model NumberR-RFS2-6-12
Catalog NumberR-RFS2-6-12
Company DUNS608625823
Company NameNORTH EAST SCIENTIFIC INC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com
Phone203-756-2111
Emailinfo@smarthealth-care.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB227RRFS2612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[B227RRFS2612]

Ethylene Oxide

[B227RRFS2612]

Ethylene Oxide

[B227RRFS2612]

Ethylene Oxide

[B227RRFS2612]

Ethylene Oxide

[B227RRFS2612]

Ethylene Oxide

[B227RRFS2612]

Ethylene Oxide

[B227RRFS2612]

Ethylene Oxide

[B227RRFS2612]

Ethylene Oxide

[B227RRFS2612]

Ethylene Oxide

[B227RRFS2612]

Ethylene Oxide

[B227RRFS2612]

Ethylene Oxide

[B227RRFS2612]

Ethylene Oxide

[B227RRFS2612]

Ethylene Oxide

[B227RRFS2612]

Ethylene Oxide

[B227RRFS2612]

Ethylene Oxide

[B227RRFS2612]

Ethylene Oxide

[B227RRFS2612]

Ethylene Oxide

[B227RRFS2612]

Ethylene Oxide

[B227RRFS2612]

Ethylene Oxide

[B227RRFS2612]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-01

On-Brand Devices [NES Reprocessed RF Stylet (RFS)]

B227RRFS2612The device is the Covidien ClosureRFS Endovenous Radiofrequency (RF) Stylet that is reprocessed
B227RRFS26120R-RFS2-6-12
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