Catalog Number

-

Brand Name

HAVEL'S

Version/Model Number

SUT. 3-0 PLAIN GUT 18"/DS-24

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

GAL

Product Code Name

Suture, Absorbable, Natural

Public Device Record Key

3fa310b8-7fb3-4891-8c79-d59ae5778110

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

June 16, 2016

Package DI Number

B070A68EL1

Quantity per Package

12

Contains DI Package

B070A68EL0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-