AccessGUDID - DEVICE: Rav Positioner (00856525007730)

GUDID

Device Identifier (DI) Information

Brand Name: Rav Positioner
Version or Model: 2030
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RAVP1000
Company Name: SUN SCIENTIFIC, INC.

Primary DI Number: 00856525007730
Issuing Agency: GS1
Commercial Distribution End Date: May 28, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 609397224 *Terms of Use

Device Description: The function of the RAV Positioner is to provide adjustable wrist positioning, and to secure the wrist during arterial access procedures. The device is adjustable to accommodate the normal variation in hand sizes. It can be used on either the Right or Left wrist and is used for a limited period during the surgical procedure. The device is to be disposed of following the procedure. The RAV Wrist Positioners are non sterile and for single patient use only and are not intended to be cleaned and reused.

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":	Yes
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?
32302	Inflatable extremity splint	A non-sterile sleeve intended to be placed around an arm or leg and inflated to immobilize and protect the limb. It is typically used by emergency medical services (EMS) as a temporary measure in emergencies, e.g., accidents and motor vehicle crashes, to stabilize the limb for transport to a hospital. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZF	Splint, Extremity, Inflatable, External

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
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: f42e03da-6454-4fd6-a14d-da6e2deb6132
Public Version Date: May 28, 2025
Public Version Number: 2
DI Record Publish Date: December 20, 2019