FDA.reportPublic FDA data

CannulaCRF

Primary DI
00811746030004
Brand
CannulaCRF
Company
CAMBRIDGE INTERVENTIONAL LLC
Model
CRF-C1010
Catalog number
CRF-C1010
Device description
CRF Radiofrequency Cannula
Published
2020-04-30
Public version status
Update
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
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
10811746030001PackageGS110In Commercial Distribution
00811746030004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081174603000110811746030001
00811746030004008117460300048117460300040811746030004

GMDN Terms#

Term, Definition table
TermDefinition
Percutaneous radio-frequency ablation probe cannula, single-useA rigid tube designed to provide percutaneous (through the skin) tissue access through its lumen for an electrosurgical probe during radio-frequency (RF) ablation procedures (typically of peripheral nerves to treat chronic pain) and for the injection/aspiration of fluids (e.g., local anaesthetic agents). It is made of metal (e.g., stainless steel), covered in insulation except for its distal tip, and includes a plastic hub; it is available in a variety of diameters and distal tip lengths/configurations. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

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
00198506091292ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
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00198506091384ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
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00860015792013AVENTIX® PFX SystemAventix Medical Inc.GEI2026-06-09
00685447020677RFP-100A™ RF Puncture GeneratorBOSTON SCIENTIFIC CORPORATIONGEI2026-06-08
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00840319759066Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764089VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764133VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
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08809306764157VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
00198506091261ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-03
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