ETHB12LT, ETHB12LT-6

GUDID 20888551043097

TROCAR BLADELESS ENDOPATH XCEL W/STABILITY SLEEVE

STERILMED, INC.

Laparoscopic trocar blade, reprocessed
Primary Device ID20888551043097
NIH Device Record Keye861cc46-01ef-4d4e-af50-394f1b4ac3fb
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberETHB12LT
Catalog NumberETHB12LT, ETHB12LT-6
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
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
GS110888551010931 [Primary]
GS120888551043097 [Package]
Contains: 10888551010931
Package: Carton [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NLMLAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20888551043097]

Ethylene Oxide


[20888551043097]

Ethylene Oxide


[20888551043097]

Ethylene Oxide


[20888551043097]

Ethylene Oxide


[20888551043097]

Ethylene Oxide


[20888551043097]

Ethylene Oxide


[20888551043097]

Ethylene Oxide


[20888551043097]

Ethylene Oxide


[20888551043097]

Ethylene Oxide


[20888551043097]

Ethylene Oxide


[20888551043097]

Ethylene Oxide


[20888551043097]

Ethylene Oxide


[20888551043097]

Ethylene Oxide


[20888551043097]

Ethylene Oxide


[20888551043097]

Ethylene Oxide


[20888551043097]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-05-06
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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