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-URS-BIO-50-70F

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)

-

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

HAO

Product Code Name

Instrument, Surgical, Non-Powered

Device Record Status

Public Device Record Key

7629a4d6-b9d0-4554-bb4d-ed7a8de55277

Public Version Date

November 12, 2021

Public Version Number

1

DI Record Publish Date

November 04, 2021

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