Catalog Number

0416-731-200

Brand Name

T7Plus

Version/Model Number

0416-731-200

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

K200493,K200493

Product Code

FYA

Product Code Name

GOWN, SURGICAL

Public Device Record Key

dd539340-659b-441e-bbd3-1f284eab60d0

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

May 11, 2020

Package DI Number

37613327466066

Quantity per Package

10

Contains DI Package

07613327466065

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack