Catalog Number

-

Brand Name

Shifeng

Version/Model Number

S-1000

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

K132553,K132553,K132553

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

c9891ba9-e462-4b64-ac0b-beb3b28f5213

Public Version Date

December 09, 2020

Public Version Number

1

DI Record Publish Date

December 01, 2020

Package DI Number

G001S10001

Quantity per Package

100

Contains DI Package

G001S10000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box