Catalog Number

ROUS1245ST

Brand Name

BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 45cm

Version/Model Number

ROUS1245ST

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

KNY

Product Code Name

Accessories, Catheter, G-U

Public Device Record Key

9a6194c9-d308-4b7d-9033-a37fd8a2f6e4

Public Version Date

December 09, 2019

Public Version Number

5

DI Record Publish Date

October 03, 2016

Package DI Number

03700512983613

Quantity per Package

5

Contains DI Package

03700512973614

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box label 2