FDA.report

Maximus Processing System Blood PRP Kit

Primary DI
B73810071
Brand
Maximus Processing System Blood PRP Kit
Company
Holding Technologies, LLC
Model
1007
Device description
To be used intraoperatively at the point of care for the safe and rapid preparation of autologous platelet concentrate (platelet rich plasma or PRP) from a small sample of peripheral blood. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect to improve handling characteristics.
Published
2021-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
ORGPlatelet And Plasma Separator For Bone Graft Handling

Product Code Classifications

CodeDeviceSpecialtyClass
ORGPlatelet And Plasma Separator For Bone Graft HandlingHematology2

Premarket Submissions

SubmissionSupplement
BK2005190

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
BK2005190

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B73810071PrimaryHIBCC0

GMDN Terms

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

Contacts

PhoneEmail
561-228-8772mm@holding-tech.com

Regulatory Flags

DUNS number
072221986
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
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
true
Sterilization required before use
false

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