FDA.reportPublic FDA data

Trel X-Press 100

Primary DI
M386XPRES1101
Brand
Trel X-Press 100
Company
Integra Lifesciences Corporation
Model
XPRES110
Catalog number
XPRES110
Device description
Trel-XPress 100, 10cc 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.
Published
2015-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQVFILLER, BONE VOID, CALCIUM COMPOUND

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061880000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061880000ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCIsotis NV2007-08-15MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780112518PrimaryGS10
M386XPRES1101SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178011251810381780112518

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, human-derivedAn sterile implantable device made primarily of human demineralized bone matrix (DBM) (acid extraction of allogeneic bone resulting in loss of most of the mineralized component but retention of proteins) intended to fill bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone. The device is bioabsorbable, osteoconductive, and has demonstrated at least potential osteoinductivity for the stimulation of new bone growth. The DBM may be combined with various carrier compounds (e.g., gelatin, hydrogel, starch) or other materials. It is available in the form of powder, crushed granules, putty, chips, or a gel that can be injected through a syringe.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvnj@integralife.com
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
083171244
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
true
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10381780541394Durepair®62106621062026-03-11
10381780541424Durepair®62158621582026-03-11
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10381780253549MAYFIELD®A1114A11142016-07-26
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10381780268666Omni-Tract®3121R3121R2018-02-23
10381780269953Omni-Tract®3810R3810R2018-02-23
10381780270072Omni-Tract®3858R3858R2018-02-23
10381780270393Omni-Tract®392239222018-02-23
10381780374121AccuDrain®SP02202017-05-08
10381780542254MAYFIELD®A4000PA4000P2026-02-05
10381780542261MAYFIELD®A4000SRLA4000SRL2026-02-05

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Primary DI, Brand, Company table
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