Catalog Number

022340

Brand Name

RAM® COR-SUTURE® QUICK LOAD®

Version/Model Number

022340

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K160529,K203081,K160529,K203081

Product Code

GAS

Product Code Name

Suture, nonabsorbable, synthetic, polyester

Public Device Record Key

519f31e1-e2ef-4097-af86-ca85f72200d1

Public Version Date

August 16, 2021

Public Version Number

5

DI Record Publish Date

March 13, 2020

Package DI Number

10850200006480

Quantity per Package

12

Contains DI Package

00850200006483

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner pack