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 00840606192002 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606192019 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606192026 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606192033 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606192040 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194884 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194891 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194907 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194914 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194921 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194938 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194945 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194952 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194969 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194976 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194983 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194990 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195003 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195010 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195027 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195034 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195041 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195058 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195065 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195539 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195669 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195676 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195683 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195690 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195706 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31
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