Catalog Number

T1000B

Brand Name

NA

Version/Model Number

T1000B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 28, 2017

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

-

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

K050163,K050163

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

535a0a5d-6f98-438e-97ab-8e4d93697275

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-