VILET - SUTURE - RIVERPOINT MEDICAL, LLC

Duns Number:964053560

Device Description: SUTURE

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More Product Details

Catalog Number

-

Brand Name

VILET

Version/Model Number

V333

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K120556,K120556

Product Code Details

Product Code

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Device Record Status

Public Device Record Key

061bb259-6ea4-433e-8d85-9259174f3b43

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

November 17, 2016

Additional Identifiers

Package DI Number

10812444026013

Quantity per Package

12

Contains DI Package

00812444026016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"RIVERPOINT MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12
2 A medical device with a moderate to high risk that requires special controls. 1369
U Unclassified 8