Catalog Number

-

Brand Name

Tech Medical Services

Version/Model Number

TM3000W

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

K103510,K103510

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

0b11164a-b341-4a14-9767-e5dfa8a7709b

Public Version Date

July 05, 2021

Public Version Number

1

DI Record Publish Date

June 27, 2021

Package DI Number

10851695005743

Quantity per Package

10

Contains DI Package

00851695005746

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box