Encompass - WRAPPER 54X54 BIAS BOUND MIST - Encompass Group, L.L.C.

Duns Number:121788819

Device Description: WRAPPER 54X54 BIAS BOUND MIST

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More Product Details

Catalog Number

-

Brand Name

Encompass

Version/Model Number

26186-054

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

7a500ec5-c83a-46a5-bc7d-d3b59a87a47c

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

50609953384363

Quantity per Package

24

Contains DI Package

00609953384368

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