AccessGUDID - DEVICE: Precise Sapphire - 120 mL LR Kit (M896PRCSAP1200)

GUDID

Device Identifier (DI) Information

Brand Name: Precise Sapphire - 120 mL LR Kit
Version or Model: PRC-SAP-120
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PRC-SAP-120
Company Name: Arteriocyte Medical Systems, Inc.

Primary DI Number: M896PRCSAP1200
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809012870 *Terms of Use

Device Description: 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.

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
ORG	Platelet And Plasma Separator For Bone Graft Handling

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
Storage Environment Temperature: between 15.5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 50804903-fedd-4b35-8cc1-d38006bdfe5e
Public Version Date: May 22, 2026
Public Version Number: 3
DI Record Publish Date: May 30, 2023