RD128210

GUDID 10888551045186

REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, D CURVE

STERILMED, INC.

Cardiac mapping catheter, percutaneous, reprocessed Cardiac mapping catheter, percutaneous, reprocessed Cardiac mapping catheter, percutaneous, reprocessed Cardiac mapping catheter, percutaneous, reprocessed Cardiac mapping catheter, percutaneous, reprocessed Cardiac mapping catheter, percutaneous, reprocessed Cardiac mapping catheter, percutaneous, reprocessed Cardiac mapping catheter, percutaneous, reprocessed Cardiac mapping catheter, percutaneous, reprocessed Cardiac mapping catheter, percutaneous, reprocessed Cardiac mapping catheter, percutaneous, reprocessed Cardiac mapping catheter, percutaneous, reprocessed Cardiac mapping catheter, percutaneous, reprocessed Cardiac mapping catheter, percutaneous, reprocessed Cardiac mapping catheter, percutaneous, reprocessed Cardiac mapping catheter, percutaneous, reprocessed Cardiac mapping catheter, percutaneous, reprocessed
Primary Device ID10888551045186
NIH Device Record Keydfc13d3d-76fc-4484-bfb0-c88bf1bb157a
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberRD128210
Catalog NumberRD128210
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
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com
Phone+1(888)541-0078
Emailsterilmedcs@its.jnj.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110888551045186 [Primary]

FDA Product Code

MTDCatheter, intracardiac mapping, high-density array

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10888551045186]

Ethylene Oxide

[10888551045186]

Ethylene Oxide

[10888551045186]

Ethylene Oxide

[10888551045186]

Ethylene Oxide

[10888551045186]

Ethylene Oxide

[10888551045186]

Ethylene Oxide

[10888551045186]

Ethylene Oxide

[10888551045186]

Ethylene Oxide

[10888551045186]

Ethylene Oxide

[10888551045186]

Ethylene Oxide

[10888551045186]

Ethylene Oxide

[10888551045186]

Ethylene Oxide

[10888551045186]

Ethylene Oxide

[10888551045186]

Ethylene Oxide

[10888551045186]

Ethylene Oxide

[10888551045186]

Ethylene Oxide

[10888551045186]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-20
Device Publish Date2021-10-12

Devices Manufactured by STERILMED, INC.

10888551045179 - NA2021-10-20 REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, F CURVE
10888551045186 - NA2021-10-20REPROCESSED PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER, D 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
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