AccessGUDID - DEVICE: AlVeo (00850014593643)

GUDID

Device Identifier (DI) Information

Brand Name: AlVeo
Version or Model: 510354
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 510354
Company Name: ROYAL BIOLOGICS INC.

Primary DI Number: 00850014593643
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080562141 *Terms of Use

Device Description: The alVeo Autologous Fibrin & Platelet System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.

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:	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 [?]
BK120008	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
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 60 Milliliter

Device Record Status

Public Device Record Key: 0ffe0271-606b-48de-b6c5-bf4873464e5d
Public Version Date: February 20, 2023
Public Version Number: 1
DI Record Publish Date: February 10, 2023