AcuSTAR Acupuncture Needles - Produced with high-quality surgical stainless - A & A MEDICAL SUPPLIES INC.

Duns Number:801197380

Device Description: Produced with high-quality surgical stainless steel, AcuSTAR acupuncture needles are desig Produced with high-quality surgical stainless steel, AcuSTAR acupuncture needles are designed for smooth and painless insertion. These Korean-type needles are sterile, disposable, single-use needles with spiral-wound handles. Ten needles with one (insertion) guide tube per sterile, individually sealed blister package. Box of 1000 needles. 0.20mm x 40mm (36# x 1.5").

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More Product Details

Catalog Number

-

Brand Name

AcuSTAR Acupuncture Needles

Version/Model Number

A2S-36-150

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)

-

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

MQX

Product Code Name

Needle, Acupuncture, Single Use

Device Record Status

Public Device Record Key

a61eb70e-b44d-4a7d-8e1b-cd2b085ce81b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 10, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"A & A MEDICAL SUPPLIES INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6