Strauss Surgical - AMERICAN MEDICAL ENDOSCOPY, INC.

Duns Number:024725124

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More Product Details

Catalog Number

-

Brand Name

Strauss Surgical

Version/Model Number

STS-2040-283BA-OLY

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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)

-

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

FAJ

Product Code Name

Cystoscope And Accessories, Flexible/Rigid

Device Record Status

Public Device Record Key

d6b3533d-0ee2-421d-9789-740e39dc592d

Public Version Date

April 29, 2020

Public Version Number

2

DI Record Publish Date

December 19, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMERICAN MEDICAL ENDOSCOPY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 79
2 A medical device with a moderate to high risk that requires special controls. 150