AccessGUDID - DEVICE: Surgical Tools for Erythrocyte and Marrow Preparation Kit (M896MAR01O1050)

GUDID

Device Identifier (DI) Information

Brand Name: Surgical Tools for Erythrocyte and Marrow Preparation Kit
Version or Model: MAR01-O-105
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ARTERIOCYTE MEDICAL SYSTEMS, INC.

Primary DI Number: M896MAR01O1050
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809012870 *Terms of Use

Device Description: Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46923	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 26ab1af3-d7dc-4853-bc93-3fc37402e346
Public Version Date: December 22, 2020
Public Version Number: 1
DI Record Publish Date: December 14, 2020