N/A 6DYNXT004

GUDID 10841898117299

Dynamic XT Steerable Diagnostic EP Catheter, 6F

INNOVATIVE HEALTH LLC

Cardiac mapping catheter, percutaneous, reprocessed
Primary Device ID10841898117299
NIH Device Record Keya217f8e7-53e2-4975-824c-c749309fa6f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberN/A
Catalog Number6DYNXT004
Company DUNS015575953
Company NameINNOVATIVE HEALTH LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Phone877-400-3740
Emailregulatory@innovative-health.com
Phone877-400-3740
Emailregulatory@innovative-health.com
Phone877-400-3740
Emailregulatory@innovative-health.com
Phone877-400-3740
Emailregulatory@innovative-health.com
Phone877-400-3740
Emailregulatory@innovative-health.com
Phone877-400-3740
Emailregulatory@innovative-health.com
Phone877-400-3740
Emailregulatory@innovative-health.com
Phone877-400-3740
Emailregulatory@innovative-health.com
Phone877-400-3740
Emailregulatory@innovative-health.com
Phone877-400-3740
Emailregulatory@innovative-health.com
Phone877-400-3740
Emailregulatory@innovative-health.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110841898117299 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-28
Device Publish Date2019-05-20

On-Brand Devices [N/A]

10841898122026Radia Steerable Diagnostic EP Catheter, 7F
10841898128691Torqr Diagnostic EP Catheter, 5F
10841898128639Torqr Diagnostic EP Catheter, 6F
10841898128233Catheter Interface Cable Response 5 ft 20/20 Black Pins
10841898128165Catheter Interface Cable, Recording System, 3 ft 4/6 Green Pins
10841898126383Inquiry Steerable Diagnostic EP Catheter 5F
10841898125393Webster CS Uni-Directional Diagnostic EP Catheter 6F
10841898125300Safire Catheter Extension Cable 10 ft 14 Black/9 Red Pins
10841898125294Safire Catheter Extension Cable 5 ft 14 Black/9 Red Pins
10841898125232Safire TX Cable - IBI Generator 1642 Catheter Interface Cable 8 ft 14 Black/14 Yellow pins
10841898125201Response EP Extension Cable 5 ft 4 Red Pins
10841898125195Response EP Extension Cable 5 ft 4 Grey Pins
10841898125171Response EP Extension Cable 5 ft 4 Black Pins
10841898123795Viking Soft Tip Diagnostic EP Catheter, 6F
10841898123757Viking Soft Tip Diagnostic EP Catheter, 6F
10841898123160Halo XP with Auto ID Diagnostic EP Catheter 7F
10841898123108Livewire Steerable Diagnostic EP Catheter, 5F
10841898123016Inquiry Steerable Diagnostic EP Catheter 7F
10841898122989Inquiry Steerable Diagnostic EP Catheter 5F
10841898122965Inquiry Steerable Diagnostic EP Catheter 5F
10841898122934Inquiry Steerable Diagnostic EP Catheter 6F
10841898122927Inquiry Steerable Diagnostic EP Catheter 6F
10841898122880Inquiry Steerable Diagnostic EP Catheter 6F
10841898122866Inquiry Steerable Diagnostic EP Catheter 6F
10841898122835Inquiry Steerable Diagnostic EP Catheter 6F
10841898122828Inquiry Steerable Diagnostic EP Catheter 6F
10841898122774Inquiry Steerable Diagnostic EP Catheter 6F
10841898122736Inquiry Steerable Diagnostic EP Catheter 6F
10841898122712Inquiry Steerable Diagnostic EP Catheter 5F
10841898122705Inquiry Steerable Diagnostic EP Catheter 5F
10841898122675Inquiry Steerable Diagnostic EP Catheter 4F
10841898122644Inquiry Steerable Diagnostic EP Catheter 5F
10841898122613Inquiry Steerable Diagnostic EP Catheter 4F
10841898122583Inquiry Steerable Diagnostic EP Catheter 4F
10841898122477Surelink Catheter Interface Cable 4 ft 4 Red Pins
10841898122460SureLink Catheter Interface Cable 4 ft Blue 4 Pins
10841898122446QwikCable Catheter Interface Cable 6 ft
10841898122057Radia Steerable Diagnostic EP Catheter, 7F
10841898122033Radia Steerable Diagnostic EP Catheter, 7F
10841898121999Radia Steerable Diagnostic EP Catheter, 7F
10841898121982Radia Steerable Diagnostic EP Catheter, 7F
10841898121395EP XT Steerable Diagnostic EP Catheter, 6F
10841898121333EP XT Steerable Diagnostic EP Catheter, 6F
10841898121142Webster Fixed Curve Diagnostic EP Catheter 6F
10841898120954Webster Fixed Curve Diagnostic EP Catheter 5F
10841898119460Viking Diagnostic EP Catheter, 6F
10841898119262Viking Diagnostic EP Catheter, 5F
10841898118562Viking Diagnostic EP Catheter, 5F
10841898117237Dynamic XT Steerable Diagnostic EP Catheter, 6F
10841898117220Dynamic XT Steerable Diagnostic EP Catheter, 6F
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.