Suction Cannula - Suction Cannula 90 Degree Small Tip 4.7mm, 24cm - KOROS U.S.A., INC.

Duns Number:007928633

Device Description: Suction Cannula 90 Degree Small Tip 4.7mm, 24cm 9-1/2"

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More Product Details

Catalog Number

8210-10

Brand Name

Suction Cannula

Version/Model Number

8210-10

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)

Yes

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

JZF

Product Code Name

Tube, Ear Suction

Device Record Status

Public Device Record Key

e57e1dab-ac4a-4db1-8cda-906d3f416e62

Public Version Date

August 09, 2022

Public Version Number

1

DI Record Publish Date

August 01, 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