Catalog Number

CTR03

Brand Name

N/A

Version/Model Number

N/A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 12, 2016

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K063788,K063788

Product Code

NLM

Product Code Name

LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

Public Device Record Key

ba587d4b-fed8-4f45-a0d3-47ce338ceab4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 12, 2016

Package DI Number

30885825016778

Quantity per Package

6

Contains DI Package

00885825016777

Package Discontinue Date

October 12, 2016

Package Status

Not in Commercial Distribution

Package Type

pack