FDA.reportPublic FDA data

NA

Primary DI
00721902070136
Brand
NA
Company
MEDTRONIC, INC.
Model
60883
Device description
FOOTSWITCH 60883 REMOTE CONTROL 10L
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OCLSurgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCLSurgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac TissueGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080509000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080509000CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICEMedtronic, Inc.2008-05-05OCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00721902070136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00721902070136007219020701367219020701360721902070136

GMDN Terms#

Term, Definition table
TermDefinition
Foot-switch, electricalAn electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000923594HeartWare™ Monitor1521MCS2026-09-25
00763000923709Power CordMCS1621PC2026-09-25
00763000923792Monitor Power CordMCS1622PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00199150027538Cardioblate™MEDTRONIC, INC.OCL2026-01-16
00763000841607Cardioblate™ Gemini™-sMEDTRONIC, INC.OCL2025-05-18
10884521851566ValleylabCovidien LPOCL2025-05-12
10840143911767AtriCure Isolator Synergy EnCapture ClampATRICURE, INC.OCL2025-03-14
30840143911761AtriCure Isolator Synergy EnCapture ClampATRICURE, INC.OCL2025-03-14
10884521829527ValleylabCovidien LPOCL2024-10-03
10884521829534ValleylabCovidien LPOCL2024-10-03
00763000841591Cardioblate™ Gemini™-sMEDTRONIC, INC.OCL2024-04-28
10840143905995AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OCL2023-02-07
10840143905834AtriCure Isolator Synergy Clamp and Guide SystemATRICURE, INC.OCL2023-02-07
30840143904817AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OCL2023-02-07
10840143905193AtriCure Isolator Synergy Clamp and Guide SystemATRICURE, INC.OCL2023-01-04
30840143904114AtriCure Isolator Synergy Clamp and Guide SystemATRICURE, INC.OCL2023-01-04
10840143905209AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OCL2023-01-04
10840143905520AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OCL2023-01-04
008105630209538mm CryoprobeVarian Medical Systems, Inc.OCL2022-02-18
008105630209608mm CryoprobeVarian Medical Systems, Inc.OCL2022-02-18
10840143904134AtriCure Isolator Synergy EnCompass Clamp and GuideSystemATRICURE, INC.OCL2021-08-12
30840143903377AtriCure Isolator Synergy EnCompass Clamp and GuideSystemATRICURE, INC.OCL2021-08-12
10840143904110AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OCL2021-07-29
10840143904127AtriCure Isolator Synergy EnCompass Clamp and Guide SystemATRICURE, INC.OCL2021-07-29
30840143903803Coagulation RF CableATRICURE, INC.OCL2021-05-24
10840143904554EPi-Sense Guided Coagulation System with VisiTraxATRICURE, INC.OCL2021-05-24
10840143904561nContact RF GeneratorATRICURE, INC.OCL2021-05-24
30840143902134nContact RF GeneratorATRICURE, INC.OCL2021-05-24
10840143901454nContact RF GeneratorATRICURE, INC.OCL2021-01-11
10840143902161Isolator Surgical Ablation SystemATRICURE, INC.OCL2021-01-11
10840143902222Isolator Surgical Ablation SystemATRICURE, INC.OCL2021-01-11
10840143902253Isolator Surgical Ablation SystemATRICURE, INC.OCL2021-01-11