N/A - MTO SCR INTRF NON-CANN 5.5X30 STER - Smith & Nephew, Inc.

Duns Number:109903521

Device Description: MTO SCR INTRF NON-CANN 5.5X30 STER

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More Product Details

Catalog Number

013452

Brand Name

N/A

Version/Model Number

013452

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2020

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

Yes

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

HWC

Product Code Name

Screw, fixation, bone

Device Record Status

Public Device Record Key

b520614f-bd2c-4b7a-aabc-58f413a1e3a8

Public Version Date

July 01, 2020

Public Version Number

3

DI Record Publish Date

October 22, 2015

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