Catalog Number

PB-01000-000-00

Brand Name

Bifurcated Vaccinating Needles

Version/Model Number

PB-01000-000-00

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K012515,K012515

Product Code

LDH

Product Code Name

System, Delivery, Allergen And Vaccine

Public Device Record Key

3f02e5d8-6d2a-447c-bc58-5430125b66ac

Public Version Date

September 29, 2020

Public Version Number

1

DI Record Publish Date

September 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-