Trel X-Press 100 XPRES125

GUDID M386XPRES1251

Trel-XPress 100, 2.5cc is made using demineralized human bone mixed with poloxamer reverse phase medium. Trel-XPress 100 is formulated into a putty form and is provided in a sterile, single use package.

Integra Lifesciences Corporation

Bone matrix implant, human-derived
Primary Device IDM386XPRES1251
NIH Device Record Keyf1eeaa2f-d8ea-43d8-88ee-ed36c598286c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrel X-Press 100
Version Model NumberXPRES125
Catalog NumberXPRES125
Company DUNS083171244
Company NameIntegra Lifesciences Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
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(800)654-2873
Emailcustsvnj@integralife.com
Phone+1(800)654-2873
Emailcustsvnj@integralife.com
Phone+1(800)654-2873
Emailcustsvnj@integralife.com
Phone+1(800)654-2873
Emailcustsvnj@integralife.com
Phone+1(800)654-2873
Emailcustsvnj@integralife.com
Phone+1(800)654-2873
Emailcustsvnj@integralife.com
Phone+1(800)654-2873
Emailcustsvnj@integralife.com
Phone+1(800)654-2873
Emailcustsvnj@integralife.com
Phone+1(800)654-2873
Emailcustsvnj@integralife.com
Phone+1(800)654-2873
Emailcustsvnj@integralife.com
Phone+1(800)654-2873
Emailcustsvnj@integralife.com
Phone+1(800)654-2873
Emailcustsvnj@integralife.com
Phone+1(800)654-2873
Emailcustsvnj@integralife.com
Phone+1(800)654-2873
Emailcustsvnj@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
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

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Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780112532 [Primary]
HIBCCM386XPRES1251 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-09-22
Device Publish Date2015-09-22

On-Brand Devices [Trel X-Press 100]

M386XPRES1251Trel-XPress 100, 2.5cc is made using demineralized human bone mixed with poloxamer reverse phase
M386XPRES1051Trel-XPress 100, 5cc is made using demineralized human bone mixed with poloxamer reverse phase m
M386XPRES1101Trel-XPress 100, 10cc is made using demineralized human bone mixed with poloxamer reverse phase

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