traxi® Panniculus Retractorhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetai - Traxi Panniculus Retractor with Retentus - CLINICAL INNOVATIONS, LLC

Duns Number:809524291

Device Description: Traxi Panniculus Retractor with Retentus Technology (BMI 30-50)

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More Product Details

Catalog Number

-

Brand Name

traxi® Panniculus Retractorhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetai

Version/Model Number

PRS-0530

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"

Yes

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

CCX

Product Code Name

Support, Patient Position

Device Record Status

Public Device Record Key

3bba55e4-b52d-4e30-afd1-c54502f42b86

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

40814247020343

Quantity per Package

5

Contains DI Package

30814247020346

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CLINICAL INNOVATIONS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12
2 A medical device with a moderate to high risk that requires special controls. 36