NA - ADJUSTABLE ARM BOARD HARDWARE KIT - Smith & Nephew, Inc.

Duns Number:109903521

Device Description: ADJUSTABLE ARM BOARD HARDWARE KIT

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More Product Details

Catalog Number

72204749

Brand Name

NA

Version/Model Number

72204749

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)

Yes

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

FWZ

Product Code Name

Accessories, operating-room, table (kit)

Device Record Status

Public Device Record Key

bb46262e-b35b-4fc7-ac7d-7954bc011a19

Public Version Date

November 03, 2020

Public Version Number

4

DI Record Publish Date

April 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SMITH & NEPHEW, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10651
2 A medical device with a moderate to high risk that requires special controls. 35590
3 A medical device with high risk that requires premarket approval 351