AccessGUDID - DEVICE: ASCENT FLEXXPRP (G668FG0010)

GUDID

Device Identifier (DI) Information

Brand Name: ASCENT FLEXXPRP
Version or Model: FG-001 Platelet Rich Plasma (PRP)
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ORTHOASCENT, LLC

Primary DI Number: G668FG0010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119273976 *Terms of Use

Device Description: The Platelet Rich Plasma (PRP) Device is a single-use, sterile concentrating device. It concentrates blood components and aids in the separation of the blood components by density using a centrifuge. The PRP prepared by this device has not been evaluated for any clinical indications. The PRP prepared by this device is NOT indicated for delivery to the patient’s circulatory system.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
61377	Autologous platelet-based product centrifuge tube	A small, cylindrical container intended to temporarily store venous blood and subsequently placed in a centrifuge to produce platelet rich fibrin (PRF) or platelet rich plasma (PRP) for application to the patient from whom the blood was taken (typically for mixing with bone graft to repair bone defects and/or application to skin wounds to accelerate healing and/or achieve haemostasis). It typically includes a lid intended to be pierced with a syringe needle for blood infusion and PRF/PRP withdrawal, clot activator (e.g., silica) and/or filter for isolation of the PRF/PRP, and a rotation mechanism facilitated by centrifugation. 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 [?]
BK241083	0

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: 94761785-9516-4876-863e-4ca55f6bff5a
Public Version Date: February 27, 2026
Public Version Number: 2
DI Record Publish Date: January 05, 2026

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
G668FG0011	8	G668FG0010	In Commercial Distribution	Case
G668FG0012	2	G668FG0010	In Commercial Distribution	Case
G668FG0013	4	G668FG0010	In Commercial Distribution	Case
G668FG0014	6	G668FG0010	In Commercial Distribution	Case