Pedigo Products, Inc. - 7500-NE: Eye Stretcher, narrow. With hydraulic - PEDIGO PRODUCTS, INC.

Duns Number:008301772

Device Description: 7500-NE: Eye Stretcher, narrow. With hydraulic height adjustment, pneumatic adjustable Fow 7500-NE: Eye Stretcher, narrow. With hydraulic height adjustment, pneumatic adjustable Fowler, Recovery Knee Gatch, Quick-Release

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More Product Details

Catalog Number

7500-NE

Brand Name

Pedigo Products, Inc.

Version/Model Number

7500-NE

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"

-

For Single-Use

-

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

FPO

Product Code Name

Stretcher, Wheeled

Device Record Status

Public Device Record Key

b6cffbd7-2a11-40a0-a386-c0043f64a04f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PEDIGO PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 22