Catalog Number

NB5SHF

Brand Name

N/A

Version/Model Number

N/A

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

K062497,K062497

Product Code

NLM

Product Code Name

LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

Public Device Record Key

46e11bdb-60ad-4e5c-8a69-2ece67175c38

Public Version Date

June 08, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

30885825016563

Quantity per Package

6

Contains DI Package

00885825016562

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack