Medium Dilator Tube - Disposable Medium Dilator Tube 9mm - KOROS U.S.A., INC.

Duns Number:007928633

Device Description: Disposable Medium Dilator Tube 9mm

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More Product Details

Catalog Number

-

Brand Name

Medium Dilator Tube

Version/Model Number

7332-75D

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

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

K120590

Product Code Details

Product Code

GXZ

Product Code Name

Electrode, Needle

Device Record Status

Public Device Record Key

484e67bd-6478-4e10-8f2a-03ee933c66b1

Public Version Date

February 08, 2022

Public Version Number

1

DI Record Publish Date

January 31, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KOROS U.S.A., INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2597
2 A medical device with a moderate to high risk that requires special controls. 416