Catalog Number

010315

Brand Name

Premium Multifire TA

Version/Model Number

010315

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K801589,K801589

Product Code

FHM

Product Code Name

APPARATUS, SUTURING, STOMACH AND INTESTINAL

Public Device Record Key

4f158036-0f17-4158-9b80-44c73125006e

Public Version Date

September 10, 2018

Public Version Number

1

DI Record Publish Date

August 10, 2018

Package DI Number

20884521045962

Quantity per Package

3

Contains DI Package

10884521045965

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE