RSDSTR10G

GUDID 10888551044370

REPROCESS SDSTR 10F-90 GE

STERILMED, INC.

Intracardiac ultrasound imaging catheter, steerable, reprocessed Intracardiac ultrasound imaging catheter, steerable, reprocessed
Primary Device ID10888551044370
NIH Device Record Key21b09f51-20ce-45d4-9f56-ed6ef7a97afa
Commercial Distribution Discontinuation2019-10-22
Commercial Distribution StatusNot in Commercial Distribution
Version Model NumberRSDSTR10G
Catalog NumberRSDSTR10G
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110888551044370 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWQReprocessed intravascular ultrasound catheter

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10888551044370]

Ethylene Oxide


[10888551044370]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-10-23
Device Publish Date2016-09-22

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10888551045209 - NA2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, D CURVE
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