FDA.reportPublic FDA data

Cascade

Primary DI
00859070006043
Brand
Cascade
Company
Musculoskeletal Transplant Foundation, Inc.
Model
910048
Catalog number
910048
Device description
Autologous Platelet System-PRFM x 2
Published
2016-12-01
Public version status
Update
Distribution status
Not 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
KSSSupplies, Blood-Bank

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSSSupplies, Blood-BankHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK0200510

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0200510

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859070006043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859070006043008590700060438590700060430859070006043

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate system preparation kit, platelet concentrationA collection of sterile devices designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. It typically includes a blood withdrawal set, tubes, and syringes. Blood is collected by venous puncture and processed in a centrifuge, increasing the concentration of platelets within the plasma or fibrin matrix; this may be done at the point-of-care. The glue-like product is applied to the surface of the injured tissue or bone where its adherent properties form a haemostatic barrier and enhance regeneration. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-433-6576RA_License@mtf.org

Regulatory Flags#

DUNS number
187560545
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
W4184058150T0474DBX®0581500581502026-06-05
W4184420810T0473Legacy DBM4208104208102022-07-01
W4184420800T0473Legacy DBM4208004208002022-07-01
W4184420801T0473Legacy DBM4208014208012022-07-01
W4184420802T0473Legacy DBM4208024208022022-07-01
W4184420805T0473Legacy DBM4208054208052022-07-01
00859070006005Cascade9100469100462016-12-01
00859070006012Cascade9100449100442016-12-01
00859070006029Cascade9100479100472016-12-01
00859070006036Cascade9100509100502016-12-01
W41844300PSTT165QuickGraft430PST430PST2019-06-25
W4184227007T0473DBX2270072270072019-06-24
W4184048150T0479DBX®0481500481502016-02-19
W4184048010T0479DBX®0480100480102016-02-19
W4184048015T0479DBX®0480150480152016-02-19
W4184048025T0479DBX®0480250480252016-02-19
W4184048050T0479DBX®0480500480502016-02-19
W4184048125T0479DBX®0481250481252016-02-19
00859070006050LipoGrafter9130002018-09-21
W4184030005T0473DBX®0300050300052016-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540151300121RadTagRadtag Technologies IncKSS2025-12-30
07540151300138RadTagRadtag Technologies IncKSS2025-12-30
07540151300145RadTagRadtag Technologies IncKSS2025-12-30
07540151300152RadTagRadtag Technologies IncKSS2025-12-30
05060242472596ORTHO® Elution KitALBA BIOSCIENCE LIMITEDKSS2025-12-04
09555240405616SampLok® Sampling Kit 16mLITL ASIA PACIFIC SDN. BHD.KSS2025-06-04
19555240405613SampLok® Sampling Kit 16mLITL ASIA PACIFIC SDN. BHD.KSS2025-06-04
07540151300107AccuTagRadtag Technologies IncKSS2023-11-02
05060242477959ALBA Elution KitALBA BIOSCIENCE LIMITEDKSS2023-10-13
00810106410333Rad-Sure™ASHLAND SPECIALTY INGREDIENTS G.P.KSS2023-05-10
00810106410340Rad-Sure™ASHLAND SPECIALTY INGREDIENTS G.P.KSS2023-05-10
00810106410326Rad-Sure™ASHLAND SPECIALTY INGREDIENTS G.P.KSS2023-04-24
07540151300046RadTagRadtag Technologies IncKSS2022-12-02
07540151300053RadTagRadtag Technologies IncKSS2022-12-02
07540151300060RadTagRadtag Technologies IncKSS2022-12-02
07540151300077RadTagRadtag Technologies IncKSS2022-12-02
07540151300008RadTagRadtag Technologies IncKSS2022-12-01
07540151300015RadTagRadtag Technologies IncKSS2022-12-01
07540151300022RadTagRadtag Technologies IncKSS2022-12-01
07540151300039RadTagRadtag Technologies IncKSS2022-12-01
10812269031230Typesafe 2.0TYPENEX MEDICAL LLCKSS2022-11-21
10812269031254Typesafe 2.0TYPENEX MEDICAL LLCKSS2022-11-21
10812269031278TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
10812269031285TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
00812269031240Typesafe 2.0TYPENEX MEDICAL LLCKSS2022-11-21
00812269031264Typesafe 2.0TYPENEX MEDICAL LLCKSS2022-11-21
20812269031275TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
00812269031295TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
10810020440536Hematype Segment DeviceFresenius Kabi AGKSS2022-11-08
20810020440533Hematype Segment DeviceFresenius Kabi AGKSS2022-11-08