IMAGINA - HOYA CORPORATION

Duns Number:691519705

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

IMAGINA

Version/Model Number

EG29-i10c

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

FDS

Product Code Name

Gastroscope And Accessories, Flexible/Rigid

Device Record Status

Public Device Record Key

90171887-6829-4bf4-bd04-ecea6ac0dfea

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

July 17, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HOYA CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 133