FDA.reportPublic FDA data

Lead Adapter

Primary DI
00821329900235
Brand
Lead Adapter
Company
Greatbatch Ltd
Model
501203
Device description
Unipolar Lead to IS-1 unipolar implantable connector.
Published
2015-10-16
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

Product Codes#

Code, Name table
CodeName
DTDPacemaker Lead Adaptor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTDPacemaker Lead AdaptorCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821329900235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821329900235008213299002358213299002350821329900235

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
Length13Centimeter
Lumen/Inner Diameter4.75Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-37 Degrees Celsius66 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
968623467
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821329580499Algovita®5208-20-USA5208-202015-12-01
00821329580505Algovita®5208-40-USA5208-402015-12-01
00821329580512Algovita®5208-60-USA5208-602015-12-01
00821329580529Algovita®5212-20-USA5212-202015-12-01
00821329580536Algovita® 5212-40-USA5212-402015-12-01
00821329580543Algovita® 5212-60-USA5212-602015-12-01
00821329900204Myopore® Sutureless Myocardial Pacing Lead5112102015-05-21
00821329900228Myopore® Sutureless Myocardial Pacing Lead5112122015-05-21
00821329900211Myopore® Sutureless Myocardial Pacing Lead5112112015-05-21
00821329000317PTFE Peelable Introducer Kit1000558-00170872018-09-24
00821329000324PTFE Peelable Introducer Kit667088-35170882017-10-26
00821329000331PTFE Peelable Introducer Kit667087-35170872017-10-26
00821329000348PTFE Peelable Introducer Kit667089-35170892017-10-26
00821329000355PTFE Peelable Introducer Kit667091-35170912017-10-26
00821329000362PTFE Peelable Introducer Kit667093-35170932017-10-26
00821329000430RadialSeal™ Introducer Kit, SS WireSPC-000653-0072018-09-24
00821329000447RadialSeal™ Introducer Kit, SS WireSPC-000653-0092018-09-24
00821329000454RadialSeal™ Introducer Kit, SS WireSPC-000653-0082018-09-24
00821329000461RadialSeal™ Introducer Kit, Poly WireSPC-000654-0072018-09-24
00821329000478RadialSeal™ Introducer Kit, Poly WireSPC-000654-0082018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000812041NAMEDTRONIC, INC.DTD2025-04-12
00885672011222Lead AdaptorOscor Inc.DTD2021-08-16
00763000059460NAMEDTRONIC, INC.DTD2019-05-11
10885672102453Lead AdaptorOscor Inc.DTD2017-11-27
00836559005544Lead AdaptorOscor Inc.DTD2017-11-27
00885672008352Lead AdaptorOscor Inc.DTD2017-11-27
00885672008369Lead AdaptorOscor Inc.DTD2017-11-27
00885672008260IS4/DF4 PlugOscor Inc.DTD2017-11-21
00802526497506Lead AdaptorOscor Inc.DTD2017-11-21
00802526497513Lead AdaptorOscor Inc.DTD2017-11-21
00802526497520Lead AdaptorOscor Inc.DTD2017-11-21
00802526497537Lead AdaptorOscor Inc.DTD2017-11-21
00802526505300LV-1 PlugOscor Inc.DTD2017-11-21
00802526540608VV-PlugOscor Inc.DTD2017-11-21
00885672008277Lead AdaptorOscor Inc.DTD2017-11-15
00885672008284Lead AdaptorOscor Inc.DTD2017-11-15
00885672008291VV-PlugOscor Inc.DTD2017-11-15
00885672008307VV-PlugOscor Inc.DTD2017-11-15
00885672008314LV-1 PlugOscor Inc.DTD2017-11-15
00885672008321Lead AdaptorOscor Inc.DTD2017-11-15
00885672008338Lead AdaptorOscor Inc.DTD2017-11-15
05414734506441SJM™ST. JUDE MEDICAL, INC.DTD2017-04-10
05414734506458SJM™ST. JUDE MEDICAL, INC.DTD2017-04-10
00836559004752BIS/BLV-13Oscor Inc.DTD2016-11-10
00836559006428Lead Adaptor Bipolar/UnipolarOscor Inc.DTD2016-02-25
00836559006411BLV/BIS-10Oscor Inc.DTD2015-12-29
00836559002611C/IS-10Oscor Inc.DTD2015-10-16
00836559002642M/IS-40Oscor Inc.DTD2015-10-16
00836559002666B/IS-15Oscor Inc.DTD2015-10-16
00836559002680BIS/IS-15Oscor Inc.DTD2015-10-16