I.CO.S®

GUDID M248119582ND1

The internal extractor, with a trocar tip and a three 1.75mm/120° flat pan attachment, is inserted into the 4.0mm head screw in order to remove the implanted screw.

NEWDEAL

Orthopaedic implant inserter/extractor, reusable
Primary Device IDM248119582ND1
NIH Device Record Key45d1d5d8-5d92-4bc8-abfa-723a13cef382
Commercial Distribution StatusIn Commercial Distribution
Brand NameI.CO.S®
Version Model Number119582ND
Company DUNS536935331
Company NameNEWDEAL
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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Device Identifiers

Device Issuing AgencyDevice ID
GS110381780045991 [Primary]
HIBCCM248119582ND1 [Secondary]

FDA Product Code

HWBEXTRACTOR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M248119582ND1]

Moist Heat or Steam Sterilization

[M248119582ND1]

Moist Heat or Steam Sterilization

[M248119582ND1]

Moist Heat or Steam Sterilization

[M248119582ND1]

Moist Heat or Steam Sterilization

[M248119582ND1]

Moist Heat or Steam Sterilization

[M248119582ND1]

Moist Heat or Steam Sterilization

[M248119582ND1]

Moist Heat or Steam Sterilization

[M248119582ND1]

Moist Heat or Steam Sterilization

[M248119582ND1]

Moist Heat or Steam Sterilization

[M248119582ND1]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-02-21
Device Publish Date2017-05-26

On-Brand Devices [I.CO.S®]

M248119592ND1The internal extractor, with a trocar tip and a three 2.6mm/120° flat pan attachment, is insert
M248119582ND1The internal extractor, with a trocar tip and a three 1.75mm/120° flat pan attachment, is inser
M248119552ND1The external protection sleeve is used to protect the soft tissues while drilling the bone for t
M248119551ND1The internal protecting sleeve is used to protect the soft tissues while drilling the bone for t
M248119541ND1The drilling guide is used to guide the drill as well as to protect the soft tissues while drill
M248119506ND1The drilling guide is used to guide the drill as well as to protect the soft tissues while drill
M248119501ND1The protection sleeve is used to protect the soft tissues while drilling the bone for the 4.0mm
M248119988ND1The silicone carpet is part of the base with reference 119986ND used in the transport and the st
M248119986ND1The silicone base is part of the container with reference 119985ND used in the transport and the
M248119985ND1The stainless steel complete box is used in the transport and the sterilization of the I.CO.S®
M248119984ND1The radel insert is part of the container with reference 119985ND used in the transport and the
M248119977ND1The propylux cylinder maintains the K-wires in the removal set with reference 119975ND used in t
M248119976ND1The complete box is used in the transport and the sterillization of the I.CO.S® 6.5mm compressi
M248119974ND1The complete box is used in the transport and the sterillization of the I.CO.S® 4mm compression
M248119959ND1The lid is part of the removal set with reference 119975ND used in the transport and the sterili
M248119958ND1The base is part of the container with reference 119976ND used in the transport and the sterilli
M248119957ND1The radel lid is part of the container used in the transport and the sterillization of the I.CO
M248119956ND1The silicone base is part of the container with reference 119974ND used in the transport and the
M248119955ND1The base is part of the removal set with reference 119975ND. It is used in the transport and the
M248119953ND1The radel insert is part of the container with reference 119976ND used in the transport and the
M248119951ND1The radel insert is part of the container with reference 119974ND used in the transport and the
M248119572ND1The cannulated graduated drill, with a three lip tip and a 6.0mm diameter tri shank attachment,
M248119571ND1The long cannulated graduated drill, with a three lip tip and a 6.0mm diameter tri shank attachm
M248119546ND1The short cannulated drill, with a three lip tip and a 6.0mm diameter tri shank attachment, is u
M248119522ND1The short cannulated drill, with a three lip tip and a 6.0mm diameter tri shank attachment, is u
M248119516ND1The long cannulated drill, with a three lip tip and a 6.0mm diameter tri shank attachment, is us
M248119555ND1The cannulated internal tap is used to prepare the thread of the 6.5mm compression screws. It is
M248119525ND1The cannulated internal tap is designed to prepare the thread of the 4mm compression screw heads
M248119590ND1The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone arou
M248119580ND1The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone arou
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