N/A D128207

GUDID 10841898127748

PentaRay Nav Eco High-Density Mapping Catheter, 7F

INNOVATIVE HEALTH LLC

Cardiac mapping catheter, percutaneous, reprocessed
Primary Device ID10841898127748
NIH Device Record Keyb2ee82a6-c4db-49b6-9a81-dcb1926e3efe
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberN/A
Catalog NumberD128207
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110841898127748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NLGCatheter, Intracardiac Mapping, High-Density, Reprocessed

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-22
Device Publish Date2019-07-12

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10841898122477Surelink Catheter Interface Cable 4 ft 4 Red Pins
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10841898118562Viking Diagnostic EP Catheter, 5F
10841898117237Dynamic XT Steerable Diagnostic EP Catheter, 6F
10841898117220Dynamic XT Steerable Diagnostic EP Catheter, 6F

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