PROBASICS - PROBASICS BARIATRIC TRAPEZE - WT CAP 1,000 LBS - COMPASS HEALTH BRANDS CORP.

Duns Number:827221698

Device Description: PROBASICS BARIATRIC TRAPEZE - WT CAP 1,000 LBS (UPPER COMPONENTS)

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More Product Details

Catalog Number

-

Brand Name

PROBASICS

Version/Model Number

PBBT001

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FSA

Product Code Name

Lift, Patient, Non-Ac-Powered

Device Record Status

Public Device Record Key

9ca90df7-1362-4c6d-819c-c684169f1286

Public Version Date

November 23, 2021

Public Version Number

2

DI Record Publish Date

November 15, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COMPASS HEALTH BRANDS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 62
2 A medical device with a moderate to high risk that requires special controls. 273
U Unclassified 2