R3 - R3 HEX ADAPTER - Smith & Nephew, Inc.

Duns Number:109903521

Device Description: R3 HEX ADAPTER

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More Product Details

Catalog Number

E0017199-2

Brand Name

R3

Version/Model Number

E0017199-2

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

HWA

Product Code Name

IMPACTOR

Device Record Status

Public Device Record Key

3c791874-971a-40aa-8da3-bc1cb2358931

Public Version Date

December 09, 2020

Public Version Number

1

DI Record Publish Date

December 01, 2020

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