Catalog Number

-

Brand Name

N/A

Version/Model Number

EG29-i10

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

-

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

K131902,K131902

Product Code

FDS

Product Code Name

Gastroscope and accessories, flexible/rigid

Public Device Record Key

60ae8b38-5590-4a95-bd3e-72165a0f9d67

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

December 14, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-