FDA.reportPublic FDA data

Thermi Disposable RF Electrode (Qty 1)

Primary DI
00817771028986
Brand
Thermi Disposable RF Electrode (Qty 1)
Company
Celling Biosciences
Model
RFDE-VA-EU (Qty1)
Catalog number
RFDE-VA-EU
Device description
Thermi Disposable RF Electrode - Qty 1
Published
2023-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K173582000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173582000ThermiX Temperature Control Radiofrequency System, Accessories - RF ElectrodesThermigen, L.L.C2018-01-17GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817771028986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817771028986008177710289868177710289860817771028986

GMDN Terms#

Term, Definition table
TermDefinition
Medium-wave diathermy treatment system electrode, activeA hand-operated electrical conductor that is a component of a medium-wave diathermy treatment system and designed to be moved over the skin surface of a patient by an operator to deliver an electrical current at a pre-set frequency to develop heat in subcutaneous tissues. It is typically designed with permanently attached cables. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021560394
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817771027316SpineSmith Fusionary Graft Delivery System0851-00300851-00302016-12-29
00817771027323SpineSmith Fusionary Graft Delivery System0851-00610851-00612016-12-29
00817771027354SpineSmith Fusionary Graft Delivery System0851-10600851-10602016-12-28
00817771027361SpineSmith Fusionary Graft Delivery System0851-10700851-10702016-12-28
00817771027378SpineSmith Fusionary Graft Delivery System0851-30600851-30602016-12-29
00817771027385SpineSmith Fusionary Graft Delivery System0852-00010852-00012016-12-29
00817771027392SpineSmith Fusionary Graft Delivery System0852-01200852-01202016-12-29
00817771029761Solum FlowSolum Flow - 10cc1206-01002025-08-05
00817771027637SpineSmith IN:C2 Spinal Fixation System1100-0002-PL1100-0002-PL2018-02-14
00817771029815SpineSmith IN:C2 Spinal Fixation System1110-0001-PL1110-0001-PL2018-02-14
00817771029822SpineSmith IN:C2 Spinal Fixation System1110-0002-PL1110-0002-PL2018-02-14
00817771027439ART BMC System Centrifuge0882-00010882-00012025-04-11
00817771027460ART BMC System Centrifuge0882-00040882-00042025-04-11
00817771027484ART BMC System Centrifuge0882-00200882-00202025-04-11
00817771028788Celling ART BMC Plus 0866-00020866-00022025-04-11
00817771028795Celling ART BMC 0886-00010886-00012025-04-11
00817771028825Celling ART PRP 2-Step 60 Kit1651-00041651-00042025-04-11
00817771028849Celling Cardio Application Kit0851-00030851-00032025-04-11
00817771028856Celling ART PRP 2-Step 120 Kit1651-00051651-00052025-04-11
00817771028870Celling ART PRP 2-Step Mini Kit1651-00021651-00022025-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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B382SD13798330Surgical DirectSurgical Direct, Inc.GEI2026-10-06
00190776433284MillenniumAvalign Technologies, Inc.GEI2026-10-05
00848657078467AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657078474AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083782AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083812AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083843AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083874AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083898AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657084956AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657084963AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657084970AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657087698AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
04953170474958THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
04953170474965THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
04953170474972THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
04953170474989THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
04953170474996THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
04953170475009THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type SOLYMPUS MEDICAL SYSTEMS CORP.GEI2026-10-05
00190776433062MillenniumAvalign Technologies, Inc.GEI2026-10-01
10884521740150LigaSureCovidien LPGEI2026-10-01
00190776432980MillenniumAvalign Technologies, Inc.GEI2026-09-30
B382SD070823101310Surgical DirectSurgical Direct, Inc.GEI2026-09-30
10884450452353STAR™Merit Medical Systems, Inc.GEI2026-09-29
00190776432645MillenniumAvalign Technologies, Inc.GEI2026-09-28
00197998302718Solventum™Solventum US LLCGEI2026-09-25
00724995269586Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25
00724995269951Snowden-PencerSTERIS Deutschland GmbHGEI2026-09-25