Aspirating Needle - 16 Gauge x 3.5" Aspirating Needle, W/ Blunt - INTERNATIONAL MEDICAL INDUSTRIES INC.

Duns Number:053469565

Device Description: 16 Gauge x 3.5" Aspirating Needle, W/ Blunt Cannula. Sterile, Individually Blister Packed, 16 Gauge x 3.5" Aspirating Needle, W/ Blunt Cannula. Sterile, Individually Blister Packed, Box of 100

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More Product Details

Catalog Number

32-34

Brand Name

Aspirating Needle

Version/Model Number

32-34

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)

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

GAA

Product Code Name

Needle, Aspiration And Injection, Disposable

Device Record Status

Public Device Record Key

06329f07-5556-4e48-b0ca-e722b5e1e16d

Public Version Date

August 09, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

B21232342

Quantity per Package

100

Contains DI Package

B21232341

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"INTERNATIONAL MEDICAL INDUSTRIES INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 15