istobiologics.comAnticoagulant Citrate Dextrose A ACD-A
Anticoagulant Citrate Dextrose A ACD-A
Arteriocyte Medical Systems, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006788678 | 3006788678 | Arteriocyte Medical Systems, Inc. | 1 | N | 2026-01-01 | 42 South St Hopkinton MA US 01748 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| M896AMS1000 | Magellan Autologous Platelet Separator System - Magellan® Autologous Platelet Separator System consists of the Platelet Separator Instrument and the associated Platelet Rich Plasma Sterile Disposable Kits. | 888-705-4786 | customerservice@istobiologics.com |
| M896AMS3000 | Magellan Complete Disposable Kit - Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the Magellan® Autologous Platelet Separator Instrument | 888-705-4786 | customerservice@istobiologics.com |
| M896AMS3050 | Magellan Basic disposable kit - Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the Magellan® Autologous Platelet Separator Instrument | 888-705-4786 | customerservice@istobiologics.com |
| M896AMS3100 | Magellan Complete One Source Kit - Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the Magellan® Autologous Platelet Separator Instrument | 888-705-4786 | customerservice@istobiologics.com |
| M896AMS3501 | Basic One Source Kit - Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the Magellan® Autologous Platelet Separator Instrument. | 8887054786 | customerservice@istobiologics.com |
| M896BTI2000 | Magellan Autologous Platelet Separator System - Magellan® Autologous Platelet Separator System consists of the Platelet Separator Instrument and the associated Platelet Rich Plasma Sterile Disposable Kits. | 888-705-4786 | customerservice@istobiologics.com |
| M896CLPTPK1010 | CP Disposable Kit - Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the Magellan® Autologous Platelet Separator Instrument. | 888-705-4786 | customerservice@istobiologics.com |
| M896CLPTPK101450 | Cellpoint CP Disposable Kit with 45mm Lightning Needle - Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the Magellan® Autologous Platelet Separator Instrument. | 888-705-4786 | customerservice@istobiologics.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 74986 | 1684252556 | K141910 | Intraosseous Cannula System Bio-MAC¿ and Bio-CORE | KNW | 2015-05-04 |
| 74986 | 1345304369 | K132905 | 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER | BRZ | 2013-10-04 |
| 74986 | 1151462760 | K111838 | INQU PASTE MIX | MQV | 2011-09-26 |
| 74986 | 1833231669 | K103799 | INQU PASTE MIX PLUS | MQV | 2011-08-29 |
| 74986 | 1285609729 | K071428 | INQU | MQV | 2007-09-17 |
| 74986 | 1575086665 | K063359 | INQU | MQV | 2007-04-16 |
| 74986 | 1566455063 | K041830 | MAGELLAN RATIO DISPENSER KIT | FMF | 2004-09-29 |
| 74986 | 1557086120 | K021902 | MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300 | JQC | 2002-08-12 |
| 74986 | 1442389560 | K020147 | MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP | FMF | 2002-04-03 |
| 74986 | 1942363433 | BK251168 | |||
| 74986 | 1816342537 | BK200540 | |||
| 74986 | 1674002612 | bk040068 | |||
| 74986 | 1762519736 | bk030040 | |||
| 74986 | 1039888223 | ||||
| 74986 | 1342865866 | ||||
| 74986 | 1445157873 |
Product Codes Associated With Registrations#
NDC#
PMN#
200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER
ARTERIOCYTE MEDICAL SYSTEMS, INC.
GUDID#
Basic One Source Kit - Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the Magellan® Autologous Platelet Separator Instrument.
2016-09-12
Magellan Autologous Platelet Separator System - Magellan® Autologous Platelet Separator System consists of the Platelet Separator Instrument and the associated Platelet Rich Plasma Sterile Disposable Kits.
2016-09-09
Magellan Complete Disposable Kit - Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the Magellan® Autologous Platelet Separator Instrument
2016-09-12
Magellan Basic disposable kit - Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the Magellan® Autologous Platelet Separator Instrument
2016-09-12
Magellan Complete One Source Kit - Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the Magellan® Autologous Platelet Separator Instrument
2016-09-12
Magellan Autologous Platelet Separator System - Magellan® Autologous Platelet Separator System consists of the Platelet Separator Instrument and the associated Platelet Rich Plasma Sterile Disposable Kits.
2016-09-09
CP Disposable Kit - Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the Magellan® Autologous Platelet Separator Instrument.
2018-12-12
Cellpoint CP Disposable Kit with 45mm Lightning Needle - Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the Magellan® Autologous Platelet Separator Instrument.
2020-02-26
Small Anchor Awl 5mm - Cannulated awls with a drive are used with a handle to prepare the pedicle for screw insertion. They match screw root dimensions, aid insertion, compact bone for fixation, and include depth markings for placement reference.
2022-12-19
Medium Anchor Awl 6mm - Cannulated awls with a drive are used with a handle to prepare the pedicle for screw insertion. They match screw root dimensions, aid insertion, compact bone for fixation, and include depth markings for placement reference.
2022-12-19
Large Anchor Awl 7mm - Cannulated awls with a drive are used with a handle to prepare the pedicle for screw insertion. They match screw root dimensions, aid insertion, compact bone for fixation, and include depth markings for placement reference.
2022-12-19
Xlarge Anchor Awl 8mm - Cannulated awls with a drive are used with a handle to prepare the pedicle for screw insertion. They match screw root dimensions, aid insertion, compact bone for fixation, and include depth markings for placement reference.
2022-12-19
Fibrant Instrument Kit - Fibrant™ Instrumentation Set is a non-sterile, single-use surgical instrument kit used in orthopedic procedures. The kit includes reusable instruments such as awls, a handle, and a graft funnel system, provided in a sterilization tray for organization, storage, and steam sterilization prior to use. The instruments are intended for the preparation of insertion sites and the delivery of bone graft material during surgical procedures.
2022-12-19
InQu Matrix 5x10cm - lnQu is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure.InQu is intended for use as a bone graft substitute in the skeletal system (extremities and pelvis). lnQu is indicated for use as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created or result from traumatic injury to the bone.
2022-06-23
InQu Paste Mix Plus 1.25cc - lnQu is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQu is intended for use as a bone graft substitute in the skeletal system (extremities and pelvis). lnQu is indicated for use as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created or result from traumatic injury to the bone.
2018-08-01
InQu Paste Mix Plus 2.5cc - lnQu is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure.InQu is intended for use as a bone graft substitute in the skeletal system (extremities and pelvis). lnQu is indicated for use as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created or result from traumatic injury to the bone.
2018-08-01
InQu Paste Mix Plus 5cc - lnQu is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQu is intended for use as a bone graft substitute in the skeletal system (extremities and pelvis). lnQu is indicated for use as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created or result from traumatic injury to the bone.
2018-08-01
InQu Paste Mix Plus 10cc - lnQu is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQu is intended for use as a bone graft substitute in the skeletal system (extremities and pelvis). lnQu is indicated for use as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created or result from traumatic injury to the bone.
2018-08-01
Magellan Autologous Platelet Separator System - Magellan ® Autologous Platelet Separator System consists of the Platelet Separator Instrument and the associated Platelet Rich Plasma Sterile Disposable Kits.
2016-09-09
Magellan Autologous Platelet Separator System - Magellan ® Autologous Platelet Separator System consists of the Platelet Separator Instrument and the associated Platelet Rich Plasma Sterile Disposable Kits.
2016-09-09
Magellan MAR0Max QuickDraw Convenience Kit - Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the Magellan® Autologous Platelet Separator Instrument
2016-09-09
Precise Diamond - 120 mL LP Kit - The Precise Cell Concentration System is a single-use platelet-rich plasma (PRP) device designed to process anticoagulated whole blood. The system consists of a canister designed to fit into a centrifuge bucket and is provided as part of a disposable kit containing the necessary components for blood processing and PRP preparation.
2023-05-30
Precise Sapphire - 120 mL LR Kit - The Precise Cell Concentration System is a single-use platelet-rich plasma (PRP) device designed to process anticoagulated whole blood. The system consists of a canister designed to fit into a centrifuge bucket and is provided as part of a disposable kit containing the necessary components for blood processing and PRP preparation.
2023-05-30
Precise Sapphire - 60 mL LR Kit - The Precise Cell Concentration System is a single-use platelet-rich plasma (PRP) device designed to process anticoagulated whole blood. The system consists of a canister designed to fit into a centrifuge bucket and is provided as part of a disposable kit containing the necessary components for blood processing and PRP preparation.
2023-05-30
Magellan Autologous Platelet Separator System - Magellan® Autologous Platelet Separator System consists of the Platelet Separator Instrument and the associated Platelet Rich Plasma Sterile Disposable Kits.
2016-09-09
Magellan Autologous Platelet Separator System - Magellan® Autologous Platelet Separator System consists of the Platelet Separator Instrument and the associated Platelet Rich Plasma Sterile Disposable Kits.
2016-09-09
Magellan Complete Disposable Kit - Sterile Disposable Kit Containing single patient-use components necessary for each platelet separation procedure with the Magellan® Autologous Platelet Separator Instrument.
2019-06-13
Precise Separation Canister, 60 mL - Sterile single-use canister centrifuge chamber designed for concentrating platelets from extracorporeal whole blood, provided as a part of a disposable PRP preparation kit.
2023-05-30
Precise Separation Canister, 60mL - Sterile single-use canister centrifuge chamber designed for concentrating platelets from extracorporeal whole blood, provided as a part of disposable PRP preparation kit.
2023-05-30
Precise Separation Canister, 60 mL - Sterile single-use canister centrifuge chamber designed for concentrating platelets from extracorporeal whole blood, provided as a part of disposable PRP preparation kit.
2023-05-30
Precise Separation Canister, 120 mL - Sterile single-use canister centrifuge chamber designed for concentrating platelets from extracorporeal whole blood, provided as a part of disposable PRP preparation kit.
2023-05-30
Precise Separation Canister, 120 mL - Sterile single-use canister centrifuge chamber designed for concentrating platelets from extracorporeal whole blood, provided as a part of disposable PRP preparation kit.
2023-05-30
Precise Separation Canister, 120 mL - Sterile single-use canister centrifuge chamber designed for concentrating platelets from extracorporeal whole blood, provided as a part of disposable PRP preparation kit.
2023-05-30
Precise Diamond 60 mL LP Kit - The Precise Cell Concentration System is a single-use platelet-rich plasma (PRP) device designed to process anticoagulated whole blood. The system consists of a canister designed to fit into a centrifuge bucket and is provided as part of a disposable kit containing the necessary components for blood processing and PRP preparation.
2023-05-30
Sterilization Tray - Reusable sterilization tray used to hold and organize surgical instruments during cleaning, sterilization, transport, and storage.
2022-11-28
InQu Granules 30cc - lnQu is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQu is intended for use as a bone graft substitute in the skeletal system (extremities and pelvis). lnQu is indicated for use as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created or result from traumatic injury to the bone.
2022-06-23
InQu Matrix 5x5cm - lnQu is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure.InQu is intended for use as a bone graft substitute in the skeletal system (extremities and pelvis). lnQu is indicated for use as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created or result from traumatic injury to the bone.
2022-06-23
Magellan Surgical Tools for Erythrocyte & Marrow Preparation Kit - Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the Magellan® Autologous Platelet Separator Instrument.
2019-12-09
Magellan Complete One Source Kit - Sterile Disposable Kit Containing single patient-use components necessary for each platelet separation procedure with the Magellan® Autologous Platelet Separator Instrument.
2020-03-04
Magellan Surgical Tools for Erythrocyte & Marrow Preparation Kit - Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the Magellan® Autologous Platelet Separator Instrument.
2019-12-09