Catalog Number

9002780

Brand Name

CUSTOMED

Version/Model Number

712057052780

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

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

BYZ

Product Code Name

Trap, Sterile Specimen

Public Device Record Key

1885575a-e3e1-48dd-a0fc-9c5f4969d7a7

Public Version Date

January 22, 2021

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

M20890027802

Quantity per Package

50

Contains DI Package

M20890027800

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

50/CS