HEPRO.US Welcome Pack - Case - 1pc Patient Gown, 1pc Round Cup, 1pc, Slipper, - HEPRO.US INC.

Duns Number:080061451

Device Description: 1pc Patient Gown, 1pc Round Cup, 1pc, Slipper, 1Pillow Cover 50x 70cm, 1pc Bed Sheet with 1pc Patient Gown, 1pc Round Cup, 1pc, Slipper, 1Pillow Cover 50x 70cm, 1pc Bed Sheet with Elastic 160x 240cm - 30 Non-Sterile Pouch Copy

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More Product Details

Catalog Number

-

Brand Name

HEPRO.US Welcome Pack - Case

Version/Model Number

CT - Welcome Pack

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

ERY

Product Code Name

Drape, Surgical, Ent

Device Record Status

Public Device Record Key

d685dcb4-be88-4f8b-bef2-41622ce06237

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 21, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HEPRO.US INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 20