Catalog Number

AUTNB12STF-3

Brand Name

NA

Version/Model Number

AUTNB12STF-3

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

K043592

Product Code

NLM

Product Code Name

LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

Public Device Record Key

7c2d8871-aeea-4051-9811-7f6a85b8f8a4

Public Version Date

June 08, 2021

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-