Economy Glide & Guide Turn Sheet - Economy Glide & Guide Turn Sheet (36" x 60") - PRIMO INC

Duns Number:958758146

Device Description: Economy Glide & Guide Turn Sheet (36" x 60")

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More Product Details

Catalog Number

GGE3660

Brand Name

Economy Glide & Guide Turn Sheet

Version/Model Number

GGE3660

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

FMR

Product Code Name

Device, Transfer, Patient, Manual

Device Record Status

Public Device Record Key

ea85aaf4-fb74-46bf-9934-e31b73a1aa8a

Public Version Date

July 08, 2021

Public Version Number

1

DI Record Publish Date

June 30, 2021

Additional Identifiers

Package DI Number

10810006684039

Quantity per Package

50

Contains DI Package

00810006684032

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"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