FDA.reportPublic FDA data

XCELL

Primary DI
B708XCPRPBV60EV1
Brand
XCELL
Company
APEX BIOLOGIX , LLC
Model
XC-PRP-BV-60EV
Device description
XCELL Platelet Concentrating System 60mL Convenience Kit (PN 90-018) created for Bioventus incorporating XC-PRP-60 (PN 90-001) and ACD-A (PN 70-111) This is an Evaluation configuration
Published
2025-01-24
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
FSMTray, Surgical, Instrument
ORGPlatelet And Plasma Separator For Bone Graft Handling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
ORGPlatelet And Plasma Separator For Bone Graft HandlingHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B708XCPRPBV60EV1PackageHIBCC10In Commercial Distribution
B708XCPRPBV60EV0PrimaryHIBCC0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-897-4910orders@apexbiologix.com

Regulatory Flags#

DUNS number
079560357
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B708XCPRPBV600XCELLXC-PRP-BV-602025-01-24
B708XCPRPBV60EV0XCELLXC-PRP-BV-60EV2025-01-24
B708XCPRPBV60NS0XCELLXC-PRP-BV-60NS2025-01-24
B708ABFVR020XCELLAB-FVR-022026-03-26
B708XCPC120XCELLXC-PC-1202026-03-26
B708XCPC60XCELLXC-PC-602026-03-26
B708ACDA130XCELLACD-A-132025-03-10
B708ACDA200XCELLACD-A-202025-03-10
B708XCPRPBV601XCELLXC-PRP-BV-602025-01-24
B708XCPRPBV60NS1XCELLXC-PRP-BV-60NS2025-01-24
B708XCBMC300XCELL XC-BMC-302023-05-18
B708XCBMC301XCELL XC-BMC-302023-05-18
B708XCPRP300XCELLXC-PRP-302023-05-18
B708XCPSPC1200XCELLXC-PSPC-1202022-11-16
B708XCPSPC1201XCELLXC-PSPC-1202022-11-16
B708XCBMASC600XCELL XC-BMA-SC-602022-04-18
B708XCBMCSC600XCELLXC-BMC-SC-602022-04-18
B708XCBMSC600XCELL XC-BMSC-602022-04-18
B708XCBMASC601XCELL XC-BMA-SC-602022-04-18
B708XCBMCSC601XCELLXC-BMC-SC-602022-04-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842078100196HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100202HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100226HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100233HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100240HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100332IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100349XMCPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078101896Jones UnionEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078102770IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078103098IO FiX TrioEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078107935XMCPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078108253APEXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078109359IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078109373CarpalFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110003CompressX2EXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110102AlignXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110133AlignXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078112182Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078112199Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078112205Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078112250Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078114025Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078114636Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078114643Omni MTPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078115305Omni MTPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078115770Omni MTPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078116661Omni PlatingEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078116678Omni PlatingEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078116685Omni PlatingEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078117200KinematX TotalEXTREMITY MEDICAL, LLCFSM2026-11-02