Catalog Number

B11-1005

Brand Name

Lapbag

Version/Model Number

B11-1005

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

adcd1ca8-b389-47ad-a477-7eae97bf7229

Public Version Date

January 11, 2019

Public Version Number

4

DI Record Publish Date

April 06, 2018

Package DI Number

88806182216653

Quantity per Package

8

Contains DI Package

18806182216654

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON