Rav Positioner Small - The function of the RAV Positioner is to provide - SUN SCIENTIFIC, INC.

Duns Number:609397224

Device Description: The function of the RAV Positioner is to provide adjustable wrist positioning, and to secu 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.

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More Product Details

Catalog Number

RAVP1000S

Brand Name

Rav Positioner Small

Version/Model Number

2030S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 22, 2026

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FZF

Product Code Name

Splint, Extremity, Inflatable, External

Device Record Status

Public Device Record Key

5e221d2b-bbe8-4945-a27d-e03e2d3d4537

Public Version Date

January 20, 2022

Public Version Number

1

DI Record Publish Date

January 12, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SUN SCIENTIFIC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 46
2 A medical device with a moderate to high risk that requires special controls. 30