Home GUDID M896PRCSAP1201 Precise Sapphire
Primary DI M896PRCSAP1201
Brand Precise Sapphire
Company ARTERIOCYTE MEDICAL SYSTEMS, INC.
Model PRC-SAP-120
Device description Precise Sapphire - 120 mL LR Kit
Published 2023-05-30
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 ORG Platelet And Plasma Separator For Bone Graft Handling
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ORG Platelet And Plasma Separator For Bone Graft Handling Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M896PRCSAP1201 Package HIBCC 5 In Commercial Distribution M896PRCSAP1200 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.
Regulatory Flags# DUNS number 809012870 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex true No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M896AMS1000 Magellan Autologous Platelet Separator System AMS100 AMS100 2016-09-09 M896AMS3000 Magellan Complete Disposable Kit AMS300 AMS300 2016-09-12 M896AMS3050 Magellan Basic disposable kit AMS305 AMS305 2016-09-12 M896AMS3100 Magellan Complete One Source Kit AMS310 AMS310 2016-09-12 M896BTI2000 Magellan Autologous Platelet Separator System BTI200 BTI200 2016-09-09 M896CLPTPK1010 CP Disposable Kit CLPT-PK-101 CLPT-PK-101 2018-12-12 M896CLPTPK101450 Cellpoint CP Disposable Kit with 45mm Lightning Needle CLPT-PK-101-45 CLPT-PK-101-45 2020-02-26 M896IBIA55600 Small Anchor Awl 5mm IB-IA-5560 IB-IA-5560 2022-12-19 M896IBIA65700 Medium Anchor Awl 6mm IB-IA-6570 IB-IA-6570 2022-12-19 M896IBIA75800 Large Anchor Awl 7mm IB-IA-7580 IB-IA-7580 2022-12-19 M896IBIA85900 Xlarge Anchor Awl 8mm IB-IA-8590 IB-IA-8590 2022-12-19 M896IBK00010 Fibrant Instrument Kit IB-K-0001 IB-K-0001 2022-12-19 M896IQSPMX1500 InQu Matrix 5x10cm IQSP-MX-150 IQSP-MX-150 2022-06-23 M896IQSPPP1010 InQu Paste Mix Plus 1.25cc IQSP-PP-101 IQSP-PP-101 2018-08-01 M896IQSPPP1020 InQu Paste Mix Plus 2.5cc IQSP-PP-102 IQSP-PP-102 2018-08-01 M896IQSPPP1050 InQu Paste Mix Plus 5cc IQSP-PP-105 IQSP-PP-105 2018-08-01 M896IQSPPP1100 InQu Paste Mix Plus 10cc IQSP-PP-110 IQSP-PP-110 2018-08-01 M896MAG1000 Magellan Autologous Platelet Separator System MAG100 MAG100 2016-09-09 M896MAG2000 Magellan Autologous Platelet Separator System MAG200 MAG200 2016-09-09 M896MAR0MAX450 Magellan MAR0Max QuickDraw Convenience Kit MAR0Max45 MAR0Max45 2016-09-09
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