Trel X-Press 100 XPRES105

GUDID M386XPRES1051

Trel-XPress 100, 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

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• Primary Device ID: M386XPRES1051
• NIH Device Record Key: 65f9e888-77cf-4114-970b-1c6742bf18fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trel X-Press 100
• Version Model Number: XPRES105
• Catalog Number: XPRES105
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
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Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780112525 [Primary]
HIBCC	M386XPRES1051 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061880

FDA Product Code

• MQV: FILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-22
• Device Publish Date: 2015-09-22

On-Brand Devices [Trel X-Press 100]

• M386XPRES1251: Trel-XPress 100, 2.5cc is made using demineralized human bone mixed with poloxamer reverse phase
• M386XPRES1051: Trel-XPress 100, 5cc is made using demineralized human bone mixed with poloxamer reverse phase m
• M386XPRES1101: Trel-XPress 100, 10cc is made using demineralized human bone mixed with poloxamer reverse phase