Encompass - 2 PLY WRAPPER 54X72 HEM CEIL - Encompass Group, L.L.C.

Duns Number:121788819

Device Description: 2 PLY WRAPPER 54X72 HEM CEIL

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More Product Details

Catalog Number

-

Brand Name

Encompass

Version/Model Number

26183-572

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

-

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

FRG

Product Code Name

Wrap, sterilization

Device Record Status

Public Device Record Key

3ec41c3b-1777-47f3-9ade-d3da4334f39e

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

50609953953293

Quantity per Package

24

Contains DI Package

00609953953298

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ENCOMPASS GROUP, L.L.C." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 112