Catalog Number

URS-OBGYN-100

Brand Name

TECO DIAGNOSTICS

Version/Model Number

URS-OBGYN-100

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

K970250

Product Code

JIL

Product Code Name

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Public Device Record Key

40d447f2-5991-4c57-a6c5-79de5c537df9

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

January 08, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-