Catalog Number

850-PG5018C3

Brand Name

Plain Gut 5-0 18" C3

Version/Model Number

850-PG5018C3

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 21, 2017

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

GAL

Product Code Name

Suture, Absorbable, Natural

Public Device Record Key

db358e2f-8813-4489-83a8-53813594ccf4

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

January 24, 2017

Package DI Number

D773850PG5018C32

Quantity per Package

12

Contains DI Package

D773850PG5018C31

Package Discontinue Date

February 21, 2017

Package Status

Not in Commercial Distribution

Package Type

-