FDA.reportPublic FDA data

XI.D-RL™

Primary DI
10885672009639
Brand
XI.D-RL™
Company
Oscor Inc.
Model
XI.D-RL
Catalog number
XI.D-RL
Device description
Disposable Extension Cable
Published
2020-04-17
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
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
10885672009639PrimaryGS10
00885672009632Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088567200963910885672009639
00885672009632008856720096328856720096320885672009632

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, single-useA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length250Centimeter

Storage And Handling#

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

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00885672012991Volante™VLT-7-55-9-S-PFVLT-7-55-9-S-PF2026-05-08
00885672013004Volante™VLT-7-55-17-SVLT-7-55-17-S2026-05-08
00885672013011Volante™VLT-7-75-17-SVLT-7-75-17-S2026-05-08
00885672013028Volante™VLT-7-90-9-SVLT-7-90-9-S2026-05-08
00885672013035Volante™VLT-8.5-55-17-SVLT-8.5-55-17-S2026-05-08
00885672013042Volante™VLT-12-90-30-SVLT-12-90-30-S2026-05-08
00885672013059Volante™VLT-13.8-71-39-SVLT-13.8-71-39-S2026-05-08
00885672013066Volante™VLT-14-55-25-SVLT-14-55-25-S2026-05-08
00885672013073Volante™VLT-14-71-25-S-NMVLT-14-71-25-S-NM2026-05-08
00885672013080DiRex™ Steerable SheathM004DSD100M004DSD1002026-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327688788N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2026-04-06
07613327643237N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
07613327643244N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.IKD2024-08-08
08033695721525NAFIAB SPAIKD2021-07-08
08033695726278NAFIAB SPAIKD2020-06-13
08033695726995NAFIAB SPAIKD2020-06-13
08054242441734NAFIAB SPAIKD2020-06-13
08054953345864NAFIAB SPAIKD2020-06-13
08698870325334FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870325341FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870325358FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870325365FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870325372FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870328588FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870329523FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870335708FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870335715FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870335722FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870335739FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336446FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336453FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336460FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336477FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336484FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336491FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336507FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336514FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336521FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336538FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22
08698870336545FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIIKD2020-05-22