Catalog Number

PXLP2043DN

Brand Name

MERICRON XL

Version/Model Number

PXLP2043DN

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

K172149,K172149

Product Code

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Public Device Record Key

9c88c8ff-bee4-4f35-bfe0-99a2d49c7625

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

March 05, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-