Catalog Number

-

Brand Name

Transem Spherical

Version/Model Number

TSET24SAS

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K161547,K161547

Product Code

MQF

Product Code Name

Catheter, Assisted Reproduction

Public Device Record Key

9d621048-1240-4b7d-af5a-b10bab0f6483

Public Version Date

January 23, 2019

Public Version Number

4

DI Record Publish Date

July 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-