RD® QUICK LOAD® - RD® QUICK LOAD® SUTURE, 2-0 POLYESTER, GREEN - LSI Solutions, Inc.

Duns Number:603420183

Device Description: RD® QUICK LOAD® SUTURE, 2-0 POLYESTER, GREEN

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More Product Details

Catalog Number

020979

Brand Name

RD® QUICK LOAD®

Version/Model Number

020979

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

K031443,K100593,K203120,K031443,K100593,K203120

Product Code Details

Product Code

GAS

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyester

Device Record Status

Public Device Record Key

9a988734-cfa7-4bc1-8a03-171869c4b948

Public Version Date

August 16, 2021

Public Version Number

8

DI Record Publish Date

December 04, 2015

Additional Identifiers

Package DI Number

10850200006145

Quantity per Package

12

Contains DI Package

00850200006148

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner pack

"LSI SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 56
2 A medical device with a moderate to high risk that requires special controls. 31