Catalog Number

-

Brand Name

Centricity

Version/Model Number

CPACS 7.0

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

-

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

K110875

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

8c829beb-a11c-4af5-8507-1517bbf933a5

Public Version Date

February 14, 2020

Public Version Number

1

DI Record Publish Date

February 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-