NA - The Bariatric Extender 4-inch Pads for the Foot - STERIS CORPORATION

Duns Number:036985604

Device Description: The Bariatric Extender 4-inch Pads for the Foot Section X-ray Top and can be used with the The Bariatric Extender 4-inch Pads for the Foot Section X-ray Top and can be used with the 3080 and or 3085 SP General Surgical Table.

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More Product Details

Catalog Number

BF559

Brand Name

NA

Version/Model Number

Table Extender

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

BWN

Product Code Name

TABLE AND ATTACHMENTS, OPERATING-ROOM

Device Record Status

Public Device Record Key

53737289-5fed-44de-b9e4-b8bd31c802b6

Public Version Date

April 12, 2021

Public Version Number

1

DI Record Publish Date

April 02, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STERIS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1528
2 A medical device with a moderate to high risk that requires special controls. 1557