First Step Bedside Kit - Flat Pouch, Krinkle Cleaning Pad - First Step Bedside Kit - Flat Pouch, Krinkle - CYGNUS MEDICAL L.L.C.

Duns Number:103169095

Device Description: First Step Bedside Kit - Flat Pouch, Krinkle Cleaning Pad - 1 Pouch

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More Product Details

Catalog Number

-

Brand Name

First Step Bedside Kit - Flat Pouch, Krinkle Cleaning Pad

Version/Model Number

EP-2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 04, 2022

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

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

MNL

Product Code Name

Accessories, Cleaning Brushes, For Endoscope

Device Record Status

Public Device Record Key

1c2bb48a-0df6-41f9-944b-63eccfc1d59a

Public Version Date

February 07, 2022

Public Version Number

3

DI Record Publish Date

September 24, 2020

Additional Identifiers

Package DI Number

10843356100249

Quantity per Package

30

Contains DI Package

00843356100242

Package Discontinue Date

February 04, 2022

Package Status

Not in Commercial Distribution

Package Type

-

"CYGNUS MEDICAL 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 146