Trel X-Press 300 XPRES310

GUDID 10381780112549

Trel-XPress 300, 10cc is made using demineralized human bone mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300 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: 10381780112549
• NIH Device Record Key: 68872dcb-6b32-4141-9925-b7c87769d946
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trel X-Press 300
• Version Model Number: XPRES310
• Catalog Number: XPRES310
• 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: true
• 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
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780112549 [Primary]
HIBCC	M386XPRES3101 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061880

FDA Product Code

• MBP: Filler, bone void, osteoinduction (w/o human growth factor)

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 300]

• M386XPRES3251: Trel-XPress 300, 2.5cc is made using demineralized human bone mixed with poloxamer resorbable re
• M386XPRES3051: Trel-XPress 300, 5cc is made using demineralized human bone mixed with poloxamer resorbable reve
• 10381780112549: Trel-XPress 300, 10cc is made using demineralized human bone mixed with poloxamer resorbable rev