Catalog Number

-

Brand Name

TEECAD

Version/Model Number

CR-P1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K180911

Product Code

FDS

Product Code Name

Gastroscope And Accessories, Flexible/Rigid

Public Device Record Key

6c5acbf1-d0a9-471b-8367-e8d128a50bb8

Public Version Date

July 15, 2019

Public Version Number

1

DI Record Publish Date

July 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-