SSD-102 - MEDIVATORS INC.

Duns Number:068199363

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More Product Details

Catalog Number

-

Brand Name

SSD-102

Version/Model Number

SSD-102

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"

-

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

K914145

Product Code Details

Product Code

FEB

Product Code Name

Accessories, Cleaning, For Endoscope

Device Record Status

Public Device Record Key

cb963a33-487a-4fa2-a070-affa8fa85555

Public Version Date

April 27, 2022

Public Version Number

5

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDIVATORS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2999
2 A medical device with a moderate to high risk that requires special controls. 362