FHC Reusable Pad For Yellow Fin Elite Stirrups - Fhc Reusable Pad For Yellow Fin Elite - FUTURE HEALTH CONCEPTS, INC.

Duns Number:037304144

Device Description: Fhc Reusable Pad For Yellow Fin Elite Stirrups/Legholders (1 Pr). Memory Foam 3-Way Stret Fhc Reusable Pad For Yellow Fin Elite Stirrups/Legholders (1 Pr). Memory Foam 3-Way Stretch Vinyl Cover.

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More Product Details

Catalog Number

BBO-AMA68SO-6S

Brand Name

FHC Reusable Pad For Yellow Fin Elite Stirrups

Version/Model Number

BBO-AMA68SO-6S

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

LWG

Product Code Name

Surgical Table Cushion

Device Record Status

Public Device Record Key

8b14453d-4037-4c36-915d-858fe907ef68

Public Version Date

September 24, 2020

Public Version Number

1

DI Record Publish Date

September 16, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FUTURE HEALTH CONCEPTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 287
2 A medical device with a moderate to high risk that requires special controls. 10