FDA.reportPublic FDA data

XI.D-MDT™

Primary DI
10836559006340
Brand
XI.D-MDT™
Company
Oscor Inc.
Model
XI.D-MDT
Catalog number
XI.D-MDT
Device description
Disposable Extension Cable
Published
2017-11-30
Public version status
Update
Distribution status
Not 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
IKDCABLE, ELECTRODE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070926000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070926000ELECTRODE/EXTENSION CABLES, MODELS ATAROscor, Inc.2007-06-07IKD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10836559006340PrimaryGS10
00836559006343Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1083655900634010836559006340
00836559006343008365590063438365590063430836559006343

GMDN Terms#

Term, Definition table
TermDefinition
Pacing/defibrillation lead electrical adaptorAn implantable device designed to adapt the electrical connectors of an implanted pacemaker and/or defibrillator pacing lead to a non-compatible pacemaker or defibrillator (i.e., when they do not meet connection design). This device is implanted with the pacemaker or defibrillator system.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(727)937-2511sales@oscor.com

Regulatory Flags#

DUNS number
101835833
Device count
5
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813502010237Introducer Kit for Impella®0052-30140052-30142017-11-18
00813502010244Introducer Kit for Impella®0052-30150052-30152017-11-18
00813502010558Introducer Kit for Impella®0052-30210052-30212017-11-18
00813502010664Introducer Kit for Impella®0052-30250052-30252017-11-30
00813502011517Introducer Kit for Impella®0052-30010052-30012017-11-30
00813502011562Introducer Kit for Impella®0052-30000052-30002017-11-30
00813502011609Introducer Kit for Impella®0052-30060052-30062017-11-19
00885672013226VV-Plug667145-303VV-PLUG2026-06-01
00885672013233LV-1 Plug667147-303LV-1 PLUG2026-06-01
00885672013240IS4/DF4 Plug667148-303IS4/DF4 PLUG2026-06-01
00885672012892Volante™VLT-6.5-45-9-SVLT-6.5-45-9-S2026-05-08
00885672012908Volante™VLT-6.5-45-17-SVLT-6.5-45-17-S2026-05-08
00885672012915Volante™VLT-6.5-55-7-S-SDVLT-6.5-55-7-S-SD2026-05-08
00885672012922Volante™VLT-6.5-55-9-SVLT-6.5-55-9-S2026-05-08
00885672012939Volante™VLT-6.5-55-9-S-PFVLT-6.5-55-9-S-PF2026-05-08
00885672012946Volante™VLT-6.5-55-17-SVLT-6.5-55-17-S2026-05-08
00885672012953Volante™VLT-6.5-90-9-SVLT-6.5-90-9-S2026-05-08
00885672012960Volante™VLT-7-45-9-SVLT-7-45-9-S2026-05-08
00885672012977Volante™VLT-7-45-17-SVLT-7-45-17-S2026-05-08
00885672012984Volante™VLT-7-55-9-SVLT-7-55-9-S2026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978035540010SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540027SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540034SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540041SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540058SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
06978035540065SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-09
00850087490122AUVONChangsha Yuhong Trading Co., LtdIKD2026-06-08
00850087490146AUVONChangsha Yuhong Trading Co., LtdIKD2026-06-08
06978035540003SublimedDongguan Goochain Technology Co., Ltd.IKD2026-06-05
00650551006602PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
00650551006619PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
00650551006626PMT CORPORATIONPMT CORPORATIONIKD2026-06-01
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07613327688788N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2026-04-06
07613327643237N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
07613327643244N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
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03664539003573NADIXI MEDICALIKD2022-07-06
03664539003580NADIXI MEDICALIKD2022-07-06
03664539003603NADIXI MEDICALIKD2022-07-06
03664539003610NADIXI MEDICALIKD2022-07-06
03664539003627NADIXI MEDICALIKD2022-07-06
03664539003634NADIXI MEDICALIKD2022-07-06
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