Synthetic Sheepskin Bed Overlay - Synthetic Sheepskin Bed Overlay (30" x 40") - PRIMO INC

Duns Number:958758146

Device Description: Synthetic Sheepskin Bed Overlay (30" x 40")

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More Product Details

Catalog Number

SS3040

Brand Name

Synthetic Sheepskin Bed Overlay

Version/Model Number

SS3040

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

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

FMR

Product Code Name

Device, Transfer, Patient, Manual

Device Record Status

Public Device Record Key

6cf31cb0-dfcc-42c5-9dc3-1b5e57afbf32

Public Version Date

September 09, 2020

Public Version Number

2

DI Record Publish Date

February 27, 2019

Additional Identifiers

Package DI Number

00810006683370

Quantity per Package

6

Contains DI Package

00810006682373

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"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