Catalog Number

SM238100

Brand Name

SHENMEN

Version/Model Number

SM238100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

MQX

Product Code Name

Needle, Acupuncture, Single Use

Public Device Record Key

17cffceb-7109-4b51-9bad-49ca7dc53da0

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 02, 2018

Package DI Number

B491SM2381007

Quantity per Package

10

Contains DI Package

B491SM2381005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-