FDA.reportPublic FDA data

CableAMG

Primary DI
00811746030677
Brand
CableAMG
Company
CAMBRIDGE INTERVENTIONAL LLC
Model
CRF-AMG
Catalog number
CRF-AMG
Device description
Cable Adapter
Published
2020-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00811746030677PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811746030677008117460306778117460306770811746030677

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
Lot or batch
true
Manufacturing date on label
true

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