Redicare - 10 Sterile Non-Adherent Pads 2x3 inch 10/box - REDICARE LLC

Duns Number:800149346

Device Description: 10 Sterile Non-Adherent Pads 2x3 inch 10/box

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More Product Details

Catalog Number

0104034

Brand Name

Redicare

Version/Model Number

Non Adherent Pad 2" x 3"

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NAB

Product Code Name

Gauze / Sponge,Nonresorbable For External Use

Device Record Status

Public Device Record Key

a6b3a783-b1ba-4d59-8073-1abb9e80fab2

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

July 28, 2020

Additional Identifiers

Package DI Number

B70901040342

Quantity per Package

48

Contains DI Package

B70901040341

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON

"REDICARE LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12
2 A medical device with a moderate to high risk that requires special controls. 2