VLP FOOT - 1.6MM TROCAR TIP WIRE 2X ENDED 150MM - Smith & Nephew, Inc.

Duns Number:109903521

Device Description: 1.6MM TROCAR TIP WIRE 2X ENDED 150MM

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More Product Details

Catalog Number

71101508

Brand Name

VLP FOOT

Version/Model Number

71101508

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

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

K120871,K120871

Product Code Details

Product Code

JDW

Product Code Name

PIN, FIXATION, THREADED

Device Record Status

Public Device Record Key

4b6875a3-4e0b-4ed3-8585-f8072ac925a3

Public Version Date

June 28, 2021

Public Version Number

4

DI Record Publish Date

August 29, 2015

Additional Identifiers

Package DI Number

23596010626725

Quantity per Package

6

Contains DI Package

03596010626721

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX

"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