Soule Medical - Hana/ProFX Style Positioning Kit - 9" Donut - SOULE CO., THE

Duns Number:032801706

Device Description: Hana/ProFX Style Positioning Kit - 9" Donut Headrest, Arm Board (Set of 2), Armboard Strap Hana/ProFX Style Positioning Kit - 9" Donut Headrest, Arm Board (Set of 2), Armboard Straps (Set of 2) , Ball/Joint Cover (Set of 2) Perineal Post Cover

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More Product Details

Catalog Number

PFXH1000

Brand Name

Soule Medical

Version/Model Number

PFXH1000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

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

CCX

Product Code Name

Support, Patient Position

Device Record Status

Public Device Record Key

dc160b16-41f6-4ee6-869d-04e5b74285c4

Public Version Date

September 23, 2022

Public Version Number

1

DI Record Publish Date

September 15, 2022

Additional Identifiers

Package DI Number

00810082224436

Quantity per Package

6

Contains DI Package

00810082222852

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"SOULE CO., THE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 203