STJ408309

GUDID 10888551044912

Agilis NxT Steerable Introducer: Bi-Directional, Small Curl 16.8 mm, 71 cm, 8.5F ID; Dilator: 94 cm

STERILMED, INC.

Cardiac transseptal access set
Primary Device ID10888551044912
NIH Device Record Keycd9f8241-8d3b-4f40-a694-f3ecec41ef09
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSTJ408309
Catalog NumberSTJ408309
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
Emailcustomerservice@sterilmed.com
Phone+1(888)541-0078
Emailcustomerservice@sterilmed.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
GS110888551044912 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PNEReprocessed catheter introducer

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10888551044912]

Ethylene Oxide


[10888551044912]

Ethylene Oxide


[10888551044912]

Ethylene Oxide


[10888551044912]

Ethylene Oxide


[10888551044912]

Ethylene Oxide


[10888551044912]

Ethylene Oxide


[10888551044912]

Ethylene Oxide


[10888551044912]

Ethylene Oxide


[10888551044912]

Ethylene Oxide


[10888551044912]

Ethylene Oxide


[10888551044912]

Ethylene Oxide


[10888551044912]

Ethylene Oxide


[10888551044912]

Ethylene Oxide


[10888551044912]

Ethylene Oxide


[10888551044912]

Ethylene Oxide


[10888551044912]

Ethylene Oxide


[10888551044912]

Ethylene Oxide


[10888551044912]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-01-23
Device Publish Date2016-09-22

Devices Manufactured by STERILMED, INC.

10888551045698 - Reprocessed DECANAV EP Catheter, D Curve2024-11-25 Reprocessed DECANAV EP Catheter, D Curve, 7Fr, 115cm, Electrodes: 11, SP:2-8-2mm, Tip Length: 2.4mm, Pin Connector:34
10888551045704 - Reprocessed DECANAV EP Catheter, F Curve2024-11-25 Reprocessed DECANAV EP Catheter, F Curve, 7Fr, 115cm, Electrodes: 11, SP:2-8-2mm, Tip Length: 2.4mm, Pin Connector:34
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

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