Catalog Number

ETHB5ST, ETHB5ST-6

Brand Name

NA

Version/Model Number

ETHB5ST

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"

Yes

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

K052299,K052299

Product Code

NLM

Product Code Name

LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

Public Device Record Key

8e9d10a1-9ee3-45c8-9d6e-ec0b77b889f0

Public Version Date

June 08, 2021

Public Version Number

6

DI Record Publish Date

September 22, 2016

Package DI Number

20888551043103

Quantity per Package

6

Contains DI Package

10888551018777

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton