Catalog Number

-

Brand Name

Tech Medical Services

Version/Model Number

TM500

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"

Yes

For Single-Use

Yes

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

NWV

Product Code Name

Laparoscopic Accessories, Gynecologic

Public Device Record Key

4e43eec0-f675-4acd-9dd4-7d07ed97dc82

Public Version Date

May 10, 2021

Public Version Number

4

DI Record Publish Date

October 13, 2016

Package DI Number

10851695005033

Quantity per Package

10

Contains DI Package

00851695005036

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-