Catalog Number

-

Brand Name

n.a.

Version/Model Number

021099-10

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

K180977,K180977

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

1e5cee40-3831-4214-861b-d280795e2aba

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-