Home GUDID B708XCPRPBV60EV1 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 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 B708XCPRPBV60EV1 Package HIBCC 10 In Commercial Distribution B708XCPRPBV60EV0 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 00190776422011 Millennium Avalign Technologies, Inc. FSM 2026-07-24 00840536823717 VerteGlide Spinal Growth Guidance System ORTHOPEDIATRICS CORP. FSM 2026-07-24 00840536823724 VerteGlide Spinal Growth Guidance System ORTHOPEDIATRICS CORP. FSM 2026-07-24 07640221370846 SCALA SpineArt SA FSM 2026-07-24 07640221370853 SCALA SpineArt SA FSM 2026-07-24 07640221370860 SCALA SpineArt SA FSM 2026-07-24 00190776421991 Millennium Avalign Technologies, Inc. FSM 2026-07-23 00190776422004 Millennium Avalign Technologies, Inc. FSM 2026-07-23 18059015378368 Flexible Reamers System ORTHOFIX SRL FSM 2026-07-23 18059015378375 Flexible Reamers System ORTHOFIX SRL FSM 2026-07-23 18059015378382 Flexible Reamers System ORTHOFIX SRL FSM 2026-07-23 00841731153258 ARTEMIS FUZE VILEX LLC FSM 2026-07-22 00841731153265 ARTEMIS TAKEDOWN VILEX LLC FSM 2026-07-22 B803PW12A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW14G0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW18A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW20 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW22A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW26A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW30A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW32A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW40A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW6G0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 00840606195737 Viaduct SPINAL ELEMENTS, INC. FSM 2026-07-20 00843059127478 Lattus TEDAN SURGICAL INNOVATIONS, L.L.C. FSM 2026-07-20 07613327602241 NA Stryker Leibinger GmbH & Co. KG FSM 2026-07-17 07613327602296 NA Stryker Leibinger GmbH & Co. KG FSM 2026-07-17 07613327602302 NA Stryker Leibinger GmbH & Co. KG FSM 2026-07-17 07613327602326 NA Stryker Leibinger GmbH & Co. KG FSM 2026-07-17 07613327602418 NA Stryker Leibinger GmbH & Co. KG FSM 2026-07-17
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