FDA.reportPublic FDA data

CarriGen

Primary DI
00889024432826
Brand
CarriGen
Company
Etex Corporation
Model
76-6035
Catalog number
76-6035
Published
2016-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYCBone Grafting Material, Synthetic
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYCBone Grafting Material, SyntheticDental2
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024432826PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024432826008890244328268890244328260889024432826

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic bone graftAn artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-383-9276sales@etexcorp.com

Regulatory Flags#

DUNS number
622221141
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024205444AccuFill®201.050201.0502015-11-02
00889024406476AccuFill®201.030201.0302015-11-02
00889024501225AccuFill ® PreFill2061302061302019-12-18
00889024501232AccuFill ® PreFill2061502061502019-12-18
00889024563278N-Force Blue ™IN050-7IN050-72019-12-16
00889024563285N-Force Blue ™IN050-8IN050-82019-12-16
00889024205567CarriGen ® 76-60362015-10-24
00889024205529EquivaBone ® 76-60272015-10-24
00889024205536EquivaBone ® 76-60212015-10-24
00889024205543EquivaBone ® 76-60222015-10-24
00889024205550EquivaBone ® 76-60412015-10-24
00889024205505Beta-bsm ® 76-60252015-10-24
00889024205512Beta-bsm ® 76-60162015-10-24
00889024499690Flow-FX271-002571-00252019-01-23
00889024499706Flow-FX271-005071-00252019-01-23
00889024563254N-Force BlueIN050-6IN050-62019-01-28
00889024563261N-Force BlueIN050-5IN050-52019-01-28
00889024205451Gamma-bsm ®76-60012015-10-24
00889024205468Gamma-bsm ®76-60232015-10-24
00889024205475Gamma-bsm ®76-60052015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816125027132VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
00816125027149VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
ECUR9000301001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000305001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000310001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000405001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000410001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000430001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000510001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000530001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9000630001CERASORB M Orthocurasan AGLYC2026-06-25
ECUR9380000057CERASORB Bioactivecurasan AGLYC2026-06-25
ECUR9380000058CERASORB Bioactivecurasan AGLYC2026-06-25
ECUR9920302VerteFramecurasan AGMQV2026-06-25
ECUR9920305VerteFramecurasan AGMQV2026-06-25
ECUR9920310VerteFramecurasan AGMQV2026-06-25
ECURCCLF25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLF25250CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLF2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2512CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2525CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURH20V1000Osbone Dentalcurasan AGLYC2026-06-25
ECURTFF1050TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFF1100TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFM1050TriForm Moldable Foamcurasan AGMQV2026-06-25
ECURTFM1100TriForm Moldable Foamcurasan AGMQV2026-06-25
00849777014052Union DBM, 1ccXtant Medical Holdings, Inc.MQV2026-06-24