Catalog Number

BIO-1011S

Brand Name

Bio-Gaurd Safety Needles

Version/Model Number

BIO-1011S

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

36b5cd2c-5e96-4356-9e74-106d9b46106d

Public Version Date

May 06, 2021

Public Version Number

5

DI Record Publish Date

October 10, 2019

Package DI Number

20858835007794

Quantity per Package

8

Contains DI Package

10858835007797

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case