Wipe Down Body Wedge Set, Rounded - Wipe Down Body Wedge Set, Rounded (2 each - - PRIMO INC

Duns Number:958758146

Device Description: Wipe Down Body Wedge Set, Rounded (2 each - BPW04R) 10 ST/CA

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More Product Details

Catalog Number

BPW11R

Brand Name

Wipe Down Body Wedge Set, Rounded

Version/Model Number

BPW11R

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

FMP

Product Code Name

Protector, Skin Pressure

Device Record Status

Public Device Record Key

3744a2e0-66e9-4a0a-b7fe-bcb46ae06ed7

Public Version Date

August 03, 2021

Public Version Number

1

DI Record Publish Date

July 26, 2021

Additional Identifiers

Package DI Number

10810006683858

Quantity per Package

10

Contains DI Package

00810006683851

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

SET

"PRIMO INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 208