Catalog Number

CA3253

Brand Name

CAINA

Version/Model Number

3ml LL 25G*5/8-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

K193526,K193526,K193526

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

9953148d-798e-4e14-98b7-c4abe8c7be1b

Public Version Date

November 18, 2020

Public Version Number

1

DI Record Publish Date

November 10, 2020

Package DI Number

16971564465141

Quantity per Package

100

Contains DI Package

06971564465144

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-