FDA.reportPublic FDA data

Xpression Box

Primary DI
D742CTR0
Brand
Xpression Box
Company
INTRA-LOCK INTERNATIONAL, INC.
Model
CTR
Catalog number
CTR
Device description
Xpression Box
Published
2017-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKFInstrument, Contouring, Matrix, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKFInstrument, Contouring, Matrix, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D742CTR0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate systemAn assembly of devices typically used at the point-of-care to concentrate platelets or bone marrow aspirate cells, through low-speed centrifugal force (e.g., 2,500 to 7,000 rpm), from a small volume of a patient's own blood/bone marrow for the rapid preparation of platelet-rich plasma (PRP) or bone marrow aspirate concentrate (BMAC). It typically consists of a centrifuge, a dedicated centrifuge tube(s) and sample collection/processing kits, a concentrate delivery unit, and various disposable applicators. After processing, the concentrates are applied to general and orthopaedic surgical sites, or pre-mixed with graft material, to assist the healing and/or graft acceptance process.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
877-330-0338info@intra-lock.com

Regulatory Flags#

DUNS number
131500998
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D742RP10ReOssRP1RP12017-02-08
D742RP20ReOssRP2RP22017-02-08
D742RP30ReOssRP3RP32017-02-08
D742RP40ReOssRP4RP42017-02-08
D742RP60ReOssRP6RP62017-02-08
D742RP70ReOssRP7RP72017-02-08
D742DE0Intra-LockDEDE2019-06-24
D742S47100BlossomS4710S47102020-03-17
D742S47110BlossomS4711S47112020-03-17
D742S47060BlossomS4706S47062019-06-12
D742S47080BlossomS4708S47082019-06-12
D742MDLOP25130MDLMDLOP2513MDLOP25132017-02-06
D742MDLOP25150MDLMDLOP2515MDLOP25152017-02-06
D742OP30100OPOP3010OP30102017-02-07
D742OP3011OPOP3011OP30112017-02-13
D742OP3013OPOP3013OP30132017-02-13
D742OP30150OPOP3015OP30152017-02-07
D742S34080BlossomS3408S34082017-02-07
D742S34100BlossomS3410S34102017-02-07
D742S34110BlossomS3411S34112017-02-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454011737COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454012093COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454012109COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454012116COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454012123COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454012130COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454012147COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454014493COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454014509COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454014653COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454014660COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454014677COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454014684COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454014691COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454015223COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454015490COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454015506COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454015827COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454015834COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-22
06954454000731COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21
06954454002049COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21
06954454003244COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21
06954454003251COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21
06954454003985COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21
06954454004562COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21
06954454004579COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21
06954454004586COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21
06954454004593COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21
06954454004609COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21
06954454004616COTISENHuanghua Promisee Dental Co., Ltd.EKF2026-10-21