Catalog Number

2108347

Brand Name

TOCO TRANSDUCER

Version/Model Number

NA

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

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

K982651

Product Code

HFM

Product Code Name

MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC)

Public Device Record Key

a76c33c6-5358-4d51-90a6-a8a40949c328

Public Version Date

September 14, 2020

Public Version Number

3

DI Record Publish Date

November 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-