Catalog Number

C0R20

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

304b6efe-6733-4f43-bf06-ad6d7b4b5d66

Public Version Date

June 08, 2021

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

30885825016365

Quantity per Package

6

Contains DI Package

00885825016364

Package Discontinue Date

October 12, 2016

Package Status

Not in Commercial Distribution

Package Type

pack