MAXX MXCB-1

GUDID 10850014593381

The Royal MAXX™ Accessory Kit is designed for use with the Royal MAXX™ PRP and BMC concentration systems. The kit contains 2 reuseable Royal MAXX Counterbalances and 2 reuseable Turn keys .

ROYAL BIOLOGICS INC.

Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration Haematological concentrate system preparation kit, platelet concentration
Primary Device ID10850014593381
NIH Device Record Keyb31324bc-76c8-4897-93b1-a2f1baa2246f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAXX
Version Model NumberMXCB
Catalog NumberMXCB-1
Company DUNS080562141
Company NameROYAL BIOLOGICS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 201-488-1549
Emailsupport@royalbiologics.com
Phone+1 201-488-1549
Emailsupport@royalbiologics.com
Phone+1 201-488-1549
Emailsupport@royalbiologics.com
Phone+1 201-488-1549
Emailsupport@royalbiologics.com
Phone+1 201-488-1549
Emailsupport@royalbiologics.com
Phone+1 201-488-1549
Emailsupport@royalbiologics.com
Phone+1 201-488-1549
Emailsupport@royalbiologics.com
Phone+1 201-488-1549
Emailsupport@royalbiologics.com
Phone+1 201-488-1549
Emailsupport@royalbiologics.com
Phone+1 201-488-1549
Emailsupport@royalbiologics.com
Phone+1 201-488-1549
Emailsupport@royalbiologics.com
Phone+1 201-488-1549
Emailsupport@royalbiologics.com
Phone+1 201-488-1549
Emailsupport@royalbiologics.com
Phone+1 201-488-1549
Emailsupport@royalbiologics.com
Phone+1 201-488-1549
Emailsupport@royalbiologics.com
Phone+1 201-488-1549
Emailsupport@royalbiologics.com

Device Dimensions

Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter
Total Volume60 Milliliter

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850014593384 [Primary]
GS110850014593381 [Package]
Contains: 00850014593384
Package: case [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ORGPlatelet And Plasma Separator For Bone Graft Handling

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-20
Device Publish Date2021-05-12

Devices Manufactured by ROYAL BIOLOGICS INC.

00850014593018 - FIBRINET2023-02-20 The FIBRINET® Accessory Kit contains accessories to the FIBRINET® System. The FIBRINET® System is designed to be used for the
00850014593025 - FIBRINET2023-02-20 The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a
00850014593032 - FIBRINET2023-02-20 The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a
10850014593626 - BioIncyte2023-02-20 The BioIncyte Autologous Fibrin & Platelet System is designed to be used for the safe and rapid preparation of autologous platel
10850014593633 - SeriVium2023-02-20 The SeriVium Autologous Fibrin & Platelet System is designed to be used for the safe and rapid preparation of autologous platele
10850014593640 - AlVeo2023-02-20 The alVeo Autologous Fibrin & Platelet System is designed to be used for the safe and rapid preparation of autologous platelet-r
00850014593650 - Bio-Reign 3D2023-02-20 Bio-Reign 3D Granules 5cc
00850014593667 - Bio-Reign 3D2023-02-20 Bio-Reign 3D Granules 10cc

Trademark Results [MAXX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MAXX
MAXX
98484994 not registered Live/Pending
Stahls' Inc.
2024-04-04
MAXX
MAXX
97529346 not registered Live/Pending
New Pride Corp
2022-08-01
MAXX
MAXX
90655293 not registered Live/Pending
Rumenco Limited
2021-04-19
MAXX
MAXX
90094527 not registered Live/Pending
Batavia B.V.
2020-08-05
MAXX
MAXX
88983487 not registered Live/Pending
Traxxas, L.P.
2018-11-30
MAXX
MAXX
88957572 not registered Live/Pending
Ag Distribution LLC
2020-06-10
MAXX
MAXX
88957547 not registered Live/Pending
Ag Distribution LLC
2020-06-10
MAXX
MAXX
88771858 not registered Live/Pending
Dayton Parts, LLC
2020-01-24
MAXX
MAXX
88696439 not registered Live/Pending
Westward Industries Ltd.
2019-11-18
MAXX
MAXX
88658395 not registered Live/Pending
CHINA LODGING HOLDINGS (HK) LIMITED
2019-10-17
MAXX
MAXX
88646790 not registered Live/Pending
Team International Group of America, Inc.
2019-10-08
MAXX
MAXX
88523788 not registered Live/Pending
Algood Casters Limited
2019-07-19

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