Catalog Number

IS-1

Brand Name

BEARE

Version/Model Number

IS-1

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

375bf1b5-ec9d-4f2b-8af8-889c93b46d22

Public Version Date

March 19, 2021

Public Version Number

1

DI Record Publish Date

March 11, 2021

Package DI Number

04895206600033

Quantity per Package

100

Contains DI Package

04895206600026

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box