NA - The Arthroscopy Knee Holder with pad set attaches - STERIS CORPORATION

Duns Number:036985604

Device Description: The Arthroscopy Knee Holder with pad set attaches to the seat section of the table with a The Arthroscopy Knee Holder with pad set attaches to the seat section of the table with a Clark Socket (not included) and is typically used for the off the end of the table arthroscopy technique.

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More Product Details

Catalog Number

BF717

Brand Name

NA

Version/Model Number

BF717

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

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Record Status

Public Device Record Key

2087825a-e5e5-4e66-97e9-2a2baf38afe9

Public Version Date

May 03, 2021

Public Version Number

1

DI Record Publish Date

April 23, 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