Catalog Number

BIO-1044S

Brand Name

BioCare Safety Needles

Version/Model Number

BIO-1044S

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

-

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

ef9aec25-3028-4c4b-951e-35f7229a8d4c

Public Version Date

May 06, 2021

Public Version Number

5

DI Record Publish Date

October 07, 2019

Package DI Number

20858835007091

Quantity per Package

8

Contains DI Package

10858835007094

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case