Encompass - PATIENT GOWN, 2X-4X, 12EA TS - Encompass Group, L.L.C.

Duns Number:121788819

Device Description: PATIENT GOWN, 2X-4X, 12EA TS PATIENT GOWN, BLUE, SBPP, 12 BULK NONWOVEN

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More Product Details

Catalog Number

-

Brand Name

Encompass

Version/Model Number

45419-100

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

Yes

Prescription Use (Rx)

Yes

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

FME

Product Code Name

Gown, Examination

Device Record Status

Public Device Record Key

504b42d8-6c04-4cf9-9f51-97bb4a04be45

Public Version Date

August 22, 2022

Public Version Number

1

DI Record Publish Date

August 12, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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