Catalog Number

011B1263

Brand Name

Prager Ext Set B1263

Version/Model Number

011B1263

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K964435,K964435,K964435

Product Code

FMG

Product Code Name

Stopcock, I.V. Set

Public Device Record Key

d824b709-1cd3-4d50-9299-d37efcff3ade

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

B360011B12632

Quantity per Package

25

Contains DI Package

B360011B12630

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX