N/A 442216J

GUDID 00885825011291

Diagnostic EP Catheter Josephson Curve, 4 electrodes, 2mm spacing, 6F

STRYKER SUSTAINABILITY SOLUTIONS, INC.

Cardiac mapping catheter, percutaneous, reprocessed Cardiac mapping catheter, percutaneous, reprocessed
Primary Device ID00885825011291
NIH Device Record Keycdf5700b-45dd-484c-a282-1388994db40d
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberN/A
Catalog Number442216J
Company DUNS020198912
Company NameSTRYKER SUSTAINABILITY SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)888-3433
EmailRegulatoryAffairs2@stryker.com
Phone+1(888)888-3433
EmailRegulatoryAffairs2@stryker.com

Device Dimensions

Length110 Centimeter
Length110 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100885825011291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NLHCATHETER, RECORDING, ELECTRODE, REPROCESSED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [N/A]

00885825021030JET-X Mini Clamp 6mm to 4mm
00885825021023Carbon Rod
00885825021016Carbon Fiber Rod
00885825020958Diagnostic Ultrasound Catheter, 8F
00885825020941Diagnostic Ultrasound Catheter, 10F
00885825020927Diagnostic Ultrasound Catheter, 8F
00885825020910Diagnostic Ultrasound Catheter, 10F
00885825020903Restep Pump
30885825020898Bladeless Trocar w/Stability Sleeve
00885825020880Fast FX Strut 195mm to 311mm
00885825020859Large Combination Clamp
00885825020842Straight Post
00885825020835Multi Pin Clamp
00885825020828Angled Post
00885825020811Pin Clamp
00885825020804Rod to Rod Clamp
00885825020798Carbon Fiber Rod
00885825020781Carbon Fiber Rod
00885825020774Carbon Fiber Rod
00885825020767Carbon Fiber Rod
00885825020750Carbon Fiber Rod
00885825020743Carbon Fiber Rod
00885825020736Carbon Fiber Rod
00885825020729Carbon Fiber Rod
00885825020712Carbon Fiber Rod
00885825020705Carbon Fiber Rod
00885825020699Carbon Fiber Rod
00885825020682Carbon Fiber Rod
00885825020675MonoTube Triax Pin Clamp External Fixation System
00885825020668Adjustable Clamp
0088582502065130 Degress Outrigger Post
00885825020644Outrigger Post
00885825020637Pin Clamp
00885825020620Pin Clamp
00885825020613Adjustable Clamp
00885825020606Adjustable Clamp
00885825020590Tube to Tube Clamp
00885825020583Multi-Pin Clamp
00885825020576Rod Attachment
00885825020569Multi-Pin Clamp
00885825020361Universal Clamp
00885825020354Universal Clamp
00885825020347Universal Clamp
00885825020330Rod to Rod Clamp
00885825020323Rod to Rod Clamp
00885825020316Rod to Rod Clamp
00885825020309Rod to Rod Clamp
00885825020293Rod to Rod Clamp
00885825020286Carbon Fiber Rod
00885825020279Carbon Fiber Rod

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