FDA.reportPublic FDA data

CableASE

Primary DI
00811746033395
Brand
CableASE
Company
CAMBRIDGE INTERVENTIONAL LLC
Model
CRF-ASE
Catalog number
CRF-ASE
Device description
Cable Adapter
Published
2024-12-06
Public version status
New
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
00811746033395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811746033395008117460333958117460333950811746033395

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical cable adaptorA small connector used to join the cable(s) from a handpiece/electrode(s) (active and/or return) to the generator of an electrosurgical system. This device will typically be used when the system components are from different manufacturers and the connections are not compatible. This is a reusable device.

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
00190776402143MillenniumAvalign Technologies, Inc.GEI2026-07-19
00198506092756ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105004DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105059DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105066DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105073DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020106827DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020107626DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020107633DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110565INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110640FootswitchJeisys Medical Inc.GEI2026-07-16