Catalog Number

-

Brand Name

RESOPREN

Version/Model Number

RESOPREN

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

MXW

Product Code Name

Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)

Public Device Record Key

85d9cc0f-b3f6-4bbe-9fb5-3461bf10230b

Public Version Date

April 08, 2019

Public Version Number

2

DI Record Publish Date

February 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-