FDA.reportPublic FDA data

ElectrodeCRF

Primary DI
10811746031114
Brand
ElectrodeCRF
Company
CAMBRIDGE INTERVENTIONAL LLC
Model
CRF-N1540
Catalog number
CRF-N1540
Device description
CRF Radiofrequency Electrode
Published
2020-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192715000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192715000CRF Radiofrequency Ablation SystemCambridge Interventional, LLC2020-01-07GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811746031114PackageGS15In Commercial Distribution
00811746031117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081174603111410811746031114
00811746031117008117460311178117460311170811746031117

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency ablation systemAn assembly of devices designed to generate and apply radio-frequency (RF) electrical current for heating via an electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues, including nerves, tumours, precancerous tissue; it may be intended for coagulation however it is not intended for electrosurgical cutting. It typically includes a mains electricity (AC-powered) RF current generator, controls, cables, and an appropriate electrosurgical ablation probe, catheter, and/or handpiece with electrode(s).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781-221-5300info@cambint.com

Regulatory Flags#

DUNS number
080897872
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811746033418ProcedureKitCRFCRF-U2035-KCRF-U2035-K2026-01-13
00811746033425ProcedureKitCRFCRF-U1535-KCRF-U1535-K2026-01-13
00811746033432ProcedureKitCRFCRF-C1007-KCRF-C1007-K2026-01-13
00811746033449ProcedureKitCRFCRF-C1010-KCRF-C1010-K2026-01-13
00811746033456ProcedureKitCRFCRF-C1015-KCRF-C1015-K2026-01-13
00811746033463ProcedureKitCRFCRF-C1020-KCRF-C1020-K2026-01-13
00811746033470ProcedureKitCRFCRF-C1025-KCRF-C1025-K2026-01-13
00811746033487ProcedureKitCRFCRF-C1030-KCRF-C1030-K2026-01-13
00811746033494ProcedureKitCRFCRF-C1035-KCRF-C1035-K2026-01-13
00811746033500ProcedureKitCRFCRF-C1040-KCRF-C1040-K2026-01-13
00811746033517ProcedureKitCRFCRF-C1045-KCRF-C1045-K2026-01-13
00811746033524ProcedureKitCRFCRF-C1050-KCRF-C1050-K2026-01-13
00811746033531ProcedureKitCRFCRF-C1507-KCRF-C1507-K2026-01-13
00811746033548ProcedureKitCRFCRF-C1510-KCRF-C1510-K2026-01-13
00811746033555ProcedureKitCRFCRF-C1515-KCRF-C1515-K2026-01-13
00811746033562ProcedureKitCRFCRF-C1520-KCRF-C1520-K2026-01-13
00811746033579ProcedureKitCRFCRF-C1525-KCRF-C1525-K2026-01-13
00811746033586ProcedureKitCRFCRF-C1530-KCRF-C1530-K2026-01-13
00811746033593ProcedureKitCRFCRF-C1535-KCRF-C1535-K2026-01-13
00811746033609ProcedureKitCRFCRF-C1540-KCRF-C1540-K2026-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998302718Solventum™Solventum US LLCGEI2026-09-25
00724995269586Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269951Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269968Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00190776432300MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432317MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432324MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432430MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432447MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432454MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776431457MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432041MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432195MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432201MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776431181MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431198MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431204MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431211MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431228MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431235MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431242MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431259MillenniumAvalign Technologies, Inc.GEI2026-09-21
10840113236852BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236890BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236937BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237040BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237064BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237101BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237118BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237132BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21