Catalog Number

B11-1002

Brand Name

Lapbag

Version/Model Number

B11-1002

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"

-

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

K171726,K171726,K171726,K171726

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

cd7d05da-a57b-47cc-9421-8e93c148ad65

Public Version Date

January 11, 2019

Public Version Number

4

DI Record Publish Date

April 06, 2018

Package DI Number

88806182216622

Quantity per Package

8

Contains DI Package

18806182216623

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON