FDA.reportPublic FDA data

ATAR

Primary DI
00643169382985
Brand
ATAR
Company
Oscor Inc.
Model
53912
Catalog number
53912
Device description
Reusable 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

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
00643169382985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169382985006431693829856431693829850643169382985

GMDN Terms#

Term, Definition table
TermDefinition
Pacing/defibrillation lead electrical adaptorA sterile 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
Length20Centimeter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
101835833
Device count
1
DM exempt
true
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
04260223147760PATH ABR ElectrodesPATH medical GmbHIKD2026-08-25
00860004773733AtriAmp - Pacing CableAtrility Medical LLCIKD2026-08-18
06946725571736APKAPK Technology Co.,Ltd.IKD2026-08-15
06946725512173APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725513521APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725555262APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568439APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568446APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568453APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568460APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568477APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568484APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568491APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568507APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568514APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568521APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568538APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568545APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568552APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568569APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568576APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568705APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725568859APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569429APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569436APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569467APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725569474APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725570005APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725570142APKAPK Technology Co.,Ltd.IKD2026-08-14
06946725571040APKAPK Technology Co.,Ltd.IKD2026-08-14