Gold Tai Chi™ - High quality, painless, sterile, gold plated, - Suzhou Shenlong Medical Apparatus Co., Ltd.

Duns Number:545745192

Device Description: High quality, painless, sterile, gold plated, surgical stainless steel Chinese acupuncture High quality, painless, sterile, gold plated, surgical stainless steel Chinese acupuncture needles with spiral wound gold plated copper handle. One needle with one insertion tube per sterile, individually sealed blister package. Box of 100, 0.22 x13mm.

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More Product Details

Catalog Number

AY8603

Brand Name

Gold Tai Chi™

Version/Model Number

AY8603

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

K023787,K023787,K023787

Product Code Details

Product Code

MQX

Product Code Name

Needle, Acupuncture, Single Use

Device Record Status

Public Device Record Key

3dabe461-b87a-4a0c-b3a5-ea161a4c811c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 26, 2016

Additional Identifiers

Package DI Number

36970514320466

Quantity per Package

10

Contains DI Package

16970514320462

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"SUZHOU SHENLONG MEDICAL APPARATUS CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2