Everest & Jennings - DURA-GEL SPP-AT - GF HEALTH PRODUCTS, INC.

Duns Number:132016168

Device Description: DURA-GEL SPP-AT

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More Product Details

Catalog Number

8940228

Brand Name

Everest & Jennings

Version/Model Number

8940228

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

KIC

Product Code Name

Cushion, Flotation

Device Record Status

Public Device Record Key

954ca87e-d274-4b08-96fc-464181e80502

Public Version Date

February 03, 2021

Public Version Number

1

DI Record Publish Date

January 26, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GF HEALTH PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1068
2 A medical device with a moderate to high risk that requires special controls. 202