Catalog Number

CEV8611T1U

Brand Name

Integra®

Version/Model Number

CEV8611T1U

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

K080257

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

a5c426a7-8d13-4a7b-b078-3e1d21b29d6a

Public Version Date

August 21, 2019

Public Version Number

2

DI Record Publish Date

April 04, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-