FDA.reportPublic FDA data

BioIncyte

Primary DI
10850014593626
Brand
BioIncyte
Company
ROYAL BIOLOGICS INC.
Model
510356
Catalog number
510356
Device description
The BioIncyte Autologous Fibrin & Platelet System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.
Published
2023-02-10
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
ORGPlatelet And Plasma Separator For Bone Graft Handling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ORGPlatelet And Plasma Separator For Bone Graft HandlingHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1200080

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1200080

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850014593626PackageGS110In Commercial Distribution
00850014593629PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001459362610850014593626
00850014593629008500145936298500145936290850014593629

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate system preparation kit, platelet concentrationA collection of 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 includes single- or double- (concentric) barrel syringe(s) with connecting tubes and caps. 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. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume60Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 201-488-1549support@royalbiologics.com

Regulatory Flags#

DUNS number
080562141
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014593629BioIncyte5103565103562023-02-10
00850014593636SeriVium5103555103552023-02-10
00850014593643AlVeo5103545103542023-02-10
00850014593018FIBRINETPRFMK5103572023-02-10
00850014593025FIBRINETPRFMK5103582023-02-10
00850014593032FIBRINETPFRMK5103592023-02-10
10850014593633SeriVium5103555103552023-02-10
10850014593640AlVeo5103545103542023-02-10
00850014593650Bio-Reign 3DBR-G5BR-G52023-02-10
00850014593667Bio-Reign 3DBR-G10BR-G102023-02-10
00850014593674Bio-Reign 3DBR-G20BR-G202023-02-10
00850014593681Bio-Reign 3DBR-G30BR-G302023-02-10
00850014593698Bio-Reign 3DBR-s25x25x3BR-s25x25x32023-02-10
00850014593704Bio-Reign 3DBR-s25x50x3BR-s25x50x32023-02-10
00850014593711Bio-Reign 3DBR-s25x75x3BR-s25x75x32023-02-10
00850014593728Bio-Reign 3DBR-s25x125x3BR-s25x125x32023-02-10
00850014593735Bio-Reign 3DBR-s25x25x5BR-s25x25x52023-02-10
00850014593742Bio-Reign 3DBR-s25x50x5BR-s25x50x52023-02-10
00850014593759Bio-Reign 3DBR-s25x75x5BR-s25x75x52023-02-10
00850014593766Bio-Reign 3DBR-s25x125x5BR-s25x125x52023-02-10

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Primary DI, Brand, Company table
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