Catalog Number

4100-60P-05

Brand Name

RULTRACT

Version/Model Number

4100-60P-05

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DWS

Product Code Name

Instruments, Surgical, Cardiovascular

Public Device Record Key

488446d1-12fe-46bd-8cf6-21550338b87a

Public Version Date

December 14, 2021

Public Version Number

1

DI Record Publish Date

December 06, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-