FDA.reportPublic FDA data

Cap and Sleeve Kit

Primary DI
00821329900273
Brand
Cap and Sleeve Kit
Company
Greatbatch Ltd
Model
200952-005
Catalog number
501207
Device description
Lead adapter cap and sleeve kit.
Published
2015-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00821329900273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821329900273008213299002738213299002730821329900273

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.

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821329400339Capella™1012868-005MK51822016-04-05
00821329400346Capella™1012868-006MK51832016-04-05
08714729862413Boston Scientific Channel Steerable SheathM004CS100M004CS1002016-09-24
08714729862420Boston Scientific Channel Steerable SheathM004CS200M004CS2002016-09-24
10821329400381LI Plus 4176724176722016-10-31
10821329400398LI Plus 4176734176732016-10-31
10821329400411LI Plus 4176754176752016-10-31
10821329500074Flowguard™10684-00510684-0052016-09-24
10821329500029Flowguard™10684-00210684-0022016-09-24
10821329600378ViaPeel™10893-00210893-0022016-10-31
20821329400845RadialSeal™ Introducer Kit, Poly WireSPC-000654-0062018-09-24
20821329000670OptiSeal™ 1000092-0011000092-0012019-08-15
20821329000687OptiSeal™ 1000092-0021000092-0022019-08-15
20821329000694OptiSeal™ 1000092-0031000092-0032019-08-15
20821329000700OptiSeal™ 1000092-0041000092-0042019-08-15
00821329000713OptiSeal™ 1000093-001 1000093-001 2019-08-15
20821329000724OptiSeal™ 1000093-002 1000093-002 2019-08-15
20821329000731OptiSeal™ 1000093-003 1000093-003 2019-08-15
20821329000748OptiSeal™ 1000093-004 1000093-004 2019-08-15
20821329000755OptiSeal™ 1000093-005 1000093-005 2019-08-15

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