Leg Abduction Pillows - Large Abduction Pillow 25" X 6" X 18">6" - GENEVA HEALTHCARE, LLC

Duns Number:964459106

Device Description: Large Abduction Pillow 25" X 6" X 18">6"

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More Product Details

Catalog Number

30-304-00

Brand Name

Leg Abduction Pillows

Version/Model Number

30-304-00

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)

Yes

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

96fb44dc-e0ed-40ba-827d-b2838e03405b

Public Version Date

July 15, 2020

Public Version Number

2

DI Record Publish Date

February 24, 2020

Additional Identifiers

Package DI Number

00810044960426

Quantity per Package

6

Contains DI Package

10810044960423

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"GENEVA HEALTHCARE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 148