Single Use Aspiration Needle NA-220H/230H - Single Use Aspiration Needle NA-220H - OLYMPUS MEDICAL SYSTEMS CORP.

Duns Number:711789789

Device Description: Single Use Aspiration Needle NA-220H

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More Product Details

Catalog Number

-

Brand Name

Single Use Aspiration Needle NA-220H/230H

Version/Model Number

NA-220H-8025

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 23, 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"

Yes

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

K023272,K023272

Product Code Details

Product Code

FCG

Product Code Name

Biopsy needle

Device Record Status

Public Device Record Key

5c62efaf-163f-4bef-9379-55cc7dd1b36c

Public Version Date

June 24, 2022

Public Version Number

3

DI Record Publish Date

July 02, 2018

Additional Identifiers

Package DI Number

14953170309172

Quantity per Package

5

Contains DI Package

04953170309175

Package Discontinue Date

June 23, 2022

Package Status

Not in Commercial Distribution

Package Type

-

"OLYMPUS MEDICAL SYSTEMS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 117
2 A medical device with a moderate to high risk that requires special controls. 1962
U Unclassified 52