STRADIS - STERILE SEPARATE TUMESCENT INFILTRATION TUBING - STRADIS MEDICAL, LLC

Duns Number:174262477

Device Description: STERILE SEPARATE TUMESCENT INFILTRATION TUBING

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More Product Details

Catalog Number

-

Brand Name

STRADIS

Version/Model Number

525-022

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 25, 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"

-

For Single-Use

Yes

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

GAZ

Product Code Name

Tubing, Noninvasive

Device Record Status

Public Device Record Key

88c79459-173c-411b-848e-2a1edbeb4fde

Public Version Date

July 04, 2022

Public Version Number

5

DI Record Publish Date

June 15, 2016

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