FDA.reportPublic FDA data

NES Reprocessed RF Stylet (RFS)

Primary DI
00850044399031
Brand
NES Reprocessed RF Stylet (RFS)
Company
NORTH EAST SCIENTIFIC INC
Model
R-RFS2-6-12
Catalog number
R-RFS2-6-12
Published
2025-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, ReprocessedGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173214000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173214000NES Reprocessed RF Stylet (RFS)Northeast Scientific, Inc. (Nes)2018-03-27NUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B227RRFS2612PreviousHIBCC0
00850044399031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850044399031008500443990318500443990310850044399031

GMDN Terms#

Term, Definition table
TermDefinition
Tumour-therapy radio-frequency hyperthermia system applicator, intracorporealA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
203-756-2111sales@nescientific.com

Regulatory Flags#

DUNS number
608625823
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B227RS014R1NES Reprocessed .014 Stryker CatheterR-S014RR-S014R2024-08-15
00850044399000NES Reprocessed Varicose Vein RF CatheterCF7-7-60R-CF7-7-602025-05-21
00850044399017NES Reprocessed Varicose Vein RF CatheterCF7-7-100R-CF7-7-1002025-05-21
00850044399024NES Reprocessed Varicose Vein RF CatheterCF7-3-60R-CF7-3-602025-05-21
00850044399048EsoSure1000011000012025-05-21
00850044399055NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy CatheterR-410-152R-410-1522025-05-21
00850044399062NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy CatheterR-410-154R-410-1542025-05-21
00850044399079NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy CatheterR-420-006R-420-0062025-05-21
00850044399086NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy CatheterR-420-159R-420-1592025-05-21
00850044399093NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy CatheterR-417-152R-417-1522025-05-21
00850044399109NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy CatheterR-417-156R-417-1562025-05-21
00850044399116NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy CatheterR-414-151R-414-1512025-05-21
00850044399123NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy CatheterR-414-159R-414-1592025-05-21
00850044399130NES Reprocessed Visions PV .035 Digital IVUS CatheterR-88901R-889012025-05-21
00850044399147NES Reprocessed Visions PV .014P RX Digital IVUS CatheterR-014RR-014R2025-05-21
00850044399154NES Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterR-85900P2025-05-21
00850044399161NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Short TipR-85900PST2025-05-21
00850044399208NES Reprocessed .014 Stryker CatheterR-S014RR-S014R2025-05-21
00850044399215NES Reprocessed Eagle Eye Platinum Long Tip StrykerR-S85900PR-S85900P2025-05-21
00850044399222NES Reprocessed Eagle Eye Platinum Short Tip StrykerR-S85900PSTR-S85900PST2025-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850044399000NES Reprocessed Varicose Vein RF CatheterNORTH EAST SCIENTIFIC INCNUJ2025-05-21
00850044399017NES Reprocessed Varicose Vein RF CatheterNORTH EAST SCIENTIFIC INCNUJ2025-05-21
00850044399024NES Reprocessed Varicose Vein RF CatheterNORTH EAST SCIENTIFIC INCNUJ2025-05-21
10888277408746MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-02-14
20888277408743MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-02-14
10888277408739MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-30
20888277408736MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-30
10888277325227MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277391987MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277414907MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680326MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680333MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680340MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680357MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680371MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680395MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277680432MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277719330MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277719354MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277719378MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
10888277719392MEDLINEMEDLINE INDUSTRIES, INC.NUJ2025-01-29
B504AEAR98310ArthrexProvisionNUJ2024-09-17
B504CB1381050ConMedProvisionNUJ2024-07-01
B504CBEN60000StrykerProvisionNUJ2024-05-22
B504CBEN70000StrykerProvisionNUJ2024-05-22
00850043377009AquamantysGREEN OR LLCNUJ2024-05-16
00850043377016AquamantysGREEN OR LLCNUJ2024-05-16
00850043377023Aquamantys GREEN OR LLCNUJ2024-05-16
00850043377085AquamantysSTRYKER SUSTAINABILITY SOLUTIONS, INC.NUJ2024-05-16
00850043377092AquamantysSTRYKER SUSTAINABILITY SOLUTIONS, INC.NUJ2024-05-16