PERI-LOC VLP - PERI-LOC VLP 25MM SPIKED WASHER - Smith & Nephew, Inc.

Duns Number:109903521

Device Description: PERI-LOC VLP 25MM SPIKED WASHER

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More Product Details

Catalog Number

71171221

Brand Name

PERI-LOC VLP

Version/Model Number

71171221

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

K123055

Product Code Details

Product Code

HRS

Product Code Name

PLATE, FIXATION, BONE

Device Record Status

Public Device Record Key

010129d8-0c5a-4ccd-a452-84450eae62b6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 25, 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