BIOD7L102515RT

GUDID 10888551045032

EP CATHETER LASSO 2515 VARIABLE CIRCULAR MAPPING DECAPOLAR D TYPE

STERILMED, INC.

Cardiac mapping catheter, percutaneous, reprocessed
Primary Device ID10888551045032
NIH Device Record Keyca4f0417-05a2-481d-87e9-708e0952746b
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberBIOD7L102515RT
Catalog NumberBIOD7L102515RT
Company DUNS175899459
Company NameSTERILMED, INC.
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)541-0078
Emailcustomerservice@sterilmed.com
Phone+1(888)541-0078
Emailcustomerservice@sterilmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110888551045032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NLHCATHETER, RECORDING, ELECTRODE, REPROCESSED

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10888551045032]

Ethylene Oxide


[10888551045032]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

Devices Manufactured by STERILMED, INC.

10888551045179 - NA2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, F CURVE
10888551045186 - NA2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, D CURVE
10888551045193 - NA2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, F CURVE
10888551045209 - NA2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, D CURVE
10888551010313 - NA2021-01-22 KNIFE SET ECTRA II (PACK OF 3)
10888551021531 - NA2021-01-22 KNIVES (1) HOOK BLADE (1) TRIANGLE BLADE ENDOTRAC BLADE SYSTEM
10888551000048 - NA2020-11-06 CTS RELIEF KIT, 5PC SET
10888551012928 - NA2020-10-19 ENDO LUNG

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.