STRADIS HEALTHCARE - STRADIS MEDICAL, LLC

Duns Number:174262477

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More Product Details

Catalog Number

-

Brand Name

STRADIS HEALTHCARE

Version/Model Number

ZZ-0697

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 02, 2022

Issuing Agency

In HIBCC

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"

Yes

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

-

Product Code Details

Product Code

LRW

Product Code Name

Scissors, General, Surgical

Device Record Status

Public Device Record Key

421f1e34-ecf4-4750-b0f8-dc5703e12c73

Public Version Date

September 23, 2022

Public Version Number

3

DI Record Publish Date

February 10, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRADIS MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1226
2 A medical device with a moderate to high risk that requires special controls. 1431
U Unclassified 10