FDA.reportPublic FDA data

Trel-XC Paste

Primary DI
M386TXCPA081
Brand
Trel-XC Paste
Company
Integra Lifesciences Corporation
Model
TXCPA08
Catalog number
TXCPA08
Device description
Trel-XC Paste, 8cc is a combination of human bone that has been demineralized and cancellous bone mixed with poloxamer reverse phase medium and formulated into a paste or putty-like form. Trel-XC is provided in a sterile, single patient 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
MBPFiller, bone void, osteoinduction (w/o human growth factor)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)Orthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050642000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050642000ORTHOBLAST II PUTTY AND PASTEIsotis Orthobiologics, Inc.2005-12-05MBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780112440PrimaryGS10
M386TXCPA081SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178011244010381780112440

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)654-2873custsvcnj@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

Other Devices From This Company#

Primary DI, Brand, Model table
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20705031004334BioPatch™31502016-06-20
20705031004341BioPatch™31512016-06-20
20705031004358BioPatch™31522016-06-20
10381780541387Durepair®62105621052026-03-11
10381780541400Durepair®62110621102026-03-11
10381780541417Durepair®62111621112026-03-11
10381780541370Durepair®62100621002026-03-11
10381780541394Durepair®62106621062026-03-11
10381780541424Durepair®62158621582026-03-11
10381780537434Hermetic™ PlusINS8301INS83012024-06-28
10381780253549MAYFIELD®A1114A11142016-07-26
10381780253556MAYFIELD®A1114AA1114A2016-07-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809204338580TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338597TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338603TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338610TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338627TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338634TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338641TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338658TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338665TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338672TruForm+Hans Biomed Corp.MBP2017-07-18
08809204338689TruFormHans Biomed Corp.MBP2017-07-18
08809204338696TruFormHans Biomed Corp.MBP2017-07-18
08809204338702TruFormHans Biomed Corp.MBP2017-07-18
08809204338719TruFormHans Biomed Corp.MBP2017-07-18
08809204338726TruFormHans Biomed Corp.MBP2017-07-18
08809204338733TruFormHans Biomed Corp.MBP2017-07-18
08809204338740TruFormHans Biomed Corp.MBP2017-07-18
08809204338757TruFormHans Biomed Corp.MBP2017-07-18
08809204338764TruFormHans Biomed Corp.MBP2017-07-18
08809204338771TruFormHans Biomed Corp.MBP2017-07-18
08809204338498ExponentHans Biomed Corp.MBP2017-03-09
10885862094827OptecureExactech, Inc.MBP2016-09-19
08809204339754TruForm+Hans Biomed Corp.MBP2016-08-26
08809204339761TruForm+Hans Biomed Corp.MBP2016-08-26
08809204339778TruForm+Hans Biomed Corp.MBP2016-08-26
08809204339785TruForm+Hans Biomed Corp.MBP2016-08-26
08809204339792TruForm+Hans Biomed Corp.MBP2016-08-26
08809204339808TruForm+Hans Biomed Corp.MBP2016-08-26
08809204339815TruForm+Hans Biomed Corp.MBP2016-08-26
08809204339822TruForm+Hans Biomed Corp.MBP2016-08-26