FDA.reportPublic FDA data

GroundPadCRF

Primary DI
00811746030264
Brand
GroundPadCRF
Company
CAMBRIDGE INTERVENTIONAL LLC
Model
CRF-GP
Catalog number
CRF-GP
Device description
CRF Ground Pad
Published
2020-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
10811746030261PackageGS125In Commercial Distribution
00811746030264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081174603026110811746030261
00811746030264008117460302648117460302640811746030264

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical return electrode, single-useA dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached leads. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
080897872
Device count
1
Lot or batch
true
Expiration 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
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07613327693416MalisSTRYKER CORPORATIONGEI2026-02-25
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07613327693577MalisSTRYKER CORPORATIONGEI2026-02-25
08886479300306RhinAer+ StylusAerin Medical Inc.GEI2025-09-19
07613327556469NeptuneSTRYKER CORPORATIONGEI2025-01-30
07613327548204Neptune SafeAirSTRYKER CORPORATIONGEI2025-01-06
07613327556650NeptuneSTRYKER CORPORATIONGEI2024-12-13
07613327548129NeptuneSTRYKER CORPORATIONGEI2024-12-10
07613327548143NeptuneSTRYKER CORPORATIONGEI2024-12-10