FDA.reportPublic FDA data

N/A

Primary DI
07613327322057
Brand
N/A
Company
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Model
N/A
Catalog number
85739
Device description
Ablation Catheter Cable, Pins 14/10
Published
2017-06-14
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
NLHCATHETER, RECORDING, ELECTRODE, REPROCESSED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NLHCatheter, Recording, Electrode, ReprocessedCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112232000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112232000REPROCESSED ELECTROPHYSIOLOGY CATHETERSStryker Sustainability Solutions2011-09-26NLH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327322057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327322057076133273220577613327322057

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA 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. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length250Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)888-3433RegulatoryAffairs2@stryker.com

Regulatory Flags#

DUNS number
020198912
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327688788N/APSCIC101PSCIC1012026-04-06
07613327688764N/AAFR-00006AFR-000062026-02-10
07613327681710N/AR7219-RPR7219-RP2026-02-11
07613327687217N/AM004PF41M444M004PF41M4442025-12-16
07613327688795N/AD133701D1337012025-12-16
00850043377092Aquamantys23-112-123-112-12024-05-16
00850043377085Aquamantys23-313-123-313-12024-05-16
00850043377108Aquamantys23-113-123-113-12024-05-16
07613327682045N/AM004PF41M434M004PF41M4342025-09-29
00885825011703N/AN/A4083092016-09-23
00885825011710N/AN/A4083102016-09-23
00885825011727N/AN/AG4083242016-09-23
07613327663365N/AHAR723HAR7232025-08-27
07613327663389N/AHAR736HAR7362025-08-27
07613327663419N/AHAR745HAR7452025-08-27
37613327663366N/AHAR723HAR7232025-08-27
37613327663380N/AHAR736HAR7362025-08-27
37613327663410N/AHAR745HAR7452025-08-27
07613327487640N/AHM39SPU-HLFHM39SPU-HLF2019-07-10
07613327487671N/AHM50RPSPUHM50RPSPU2019-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344020973MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344020980MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344021000MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043439MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043446MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043453MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043460MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043477MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043484MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043491MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043514MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043538MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043545MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043552MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043569MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043583MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043590MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043606MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043613MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043620MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043637MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043651MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043668MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043675MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043682MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043699MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043705MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043712MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043729MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15
10197344043736MEDLINEMEDLINE INDUSTRIES, INC.NLH2025-10-15