FDA.reportPublic FDA data

CarriGen ®

Primary DI
00889024205567
Brand
CarriGen ®
Company
Etex Corporation
Model
76-6036
Published
2015-10-24
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
LYVLabel Or Tag, Sterile
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYCBone Grafting Material, SyntheticDental2
LYVLabel Or Tag, SterileGeneral, Plastic Surgery1
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)Orthopedic2
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024205567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024205567008890242055678890242055670889024205567

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 Volume10Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at 15-25 Degrees Celcius Keep Dry Keep Away From Sunlight

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
622221141
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
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
00889024432826CarriGen76-603576-60352016-06-02
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
00787551041699NSCL24484 Custom Med Label PackXODUS MEDICAL, INC.LYV2026-10-19
00787551041705NSCL25027 Custom Med Label PackXODUS MEDICAL, INC.LYV2026-10-19
07540277000042PharmaTagsRMAC Surgical, IncLYV2026-10-15
00199284455788BonVie+ELUTE , INC.MQV2025-08-13
00386040015243FoundationGc America Inc.LYC2024-03-12
00386040015250FoundationGc America Inc.LYC2024-03-12
00085412630731ALTAPOREApatech LtdMQV2020-11-05
00085412678146ALTAPOREApatech LtdMQV2020-11-05
00085412654362ALTAPOREApatech LtdMQV2019-12-11
00085412654379ALTAPOREApatech LtdMQV2019-12-11
00085412654386ALTAPOREApatech LtdMQV2019-12-11
00085412654393ALTAPOREApatech LtdMQV2019-12-11
00613994247612PROGENIX® PUTTY and PROGENIX® PLUSMEDTRONIC SOFAMOR DANEK, INC.MQV2019-03-29
00613994247612PROGENIX® PUTTY and PROGENIX® PLUSMEDTRONIC SOFAMOR DANEK, INC.MBP2019-03-29
00613994512758MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512758MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.LYC2018-11-18
00613994512765MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512765MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.LYC2018-11-18
00613994512772MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512772MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.LYC2018-11-18
00613994512789MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.LYC2018-11-18
00613994512789MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512796MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.LYC2018-11-18
00613994512796MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512802MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512802MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.LYC2018-11-18
00613994512819MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18
00613994512819MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.LYC2018-11-18
00613994512826MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.LYC2018-11-18
00613994512826MASTERGRAFT® Mini GranulesMEDTRONIC SOFAMOR DANEK, INC.MQV2018-11-18