Home GUDID B708XCPRPBV60NS1 XCELL
Primary DI B708XCPRPBV60NS1
Brand XCELL
Company APEX BIOLOGIX , LLC
Model XC-PRP-BV-60NS
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 a non-sterile 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 Product Codes# Code, Name table Code Name FSM Tray, Surgical, Instrument ORG Platelet And Plasma Separator For Bone Graft Handling
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FSM Tray, Surgical, Instrument General, Plastic Surgery 1 ORG Platelet And Plasma Separator For Bone Graft Handling Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B708XCPRPBV60NS1 Package HIBCC 10 In Commercial Distribution B708XCPRPBV60NS0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Haematological concentrate system preparation kit, platelet concentration A 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.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 59 Degrees Fahrenheit 86 Degrees Fahrenheit
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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840286860086 Consensus Knee System Shalby Advanced Technologies, Inc. FSM 2026-07-09 M697X07900081 Silex Sacroiliac Joint Fusion System Xtant Medical Holdings, Inc. FSM 2026-07-08 00840456220283 JMU JMU DENTAL, INC FSM 2026-07-07 00190446907466 EF1 Medshape, Inc. FSM 2026-06-25 00190446907473 EF1 Medshape, Inc. FSM 2026-06-25 00190776421724 Millennium Avalign Technologies, Inc. FSM 2026-06-24 00885556924730 EVOS Smith & Nephew, Inc. FSM 2026-06-24 00840456200308 JMU JMU DENTAL, INC FSM 2026-06-23 00840456200315 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201176 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201206 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201213 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201220 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201237 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201244 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201251 JMU JMU DENTAL, INC FSM 2026-06-23 00840456201268 JMU JMU DENTAL, INC FSM 2026-06-23 00840456206706 JMU JMU DENTAL, INC FSM 2026-06-23 00840456206713 JMU JMU DENTAL, INC FSM 2026-06-23 00840456207000 JMU JMU DENTAL, INC FSM 2026-06-23 00840456214077 JMU JMU DENTAL, INC FSM 2026-06-23 00840456214084 JMU JMU DENTAL, INC FSM 2026-06-23 00840456214091 JMU JMU DENTAL, INC FSM 2026-06-23 00840456214107 JMU JMU DENTAL, INC FSM 2026-06-23 00840456214114 JMU JMU DENTAL, INC FSM 2026-06-23 00840456214121 JMU JMU DENTAL, INC FSM 2026-06-23 00840456215098 JMU JMU DENTAL, INC FSM 2026-06-23 00840456215111 JMU JMU DENTAL, INC FSM 2026-06-23 00840456215128 JMU JMU DENTAL, INC FSM 2026-06-23 00840456217580 JMU JMU DENTAL, INC FSM 2026-06-23
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