Catalog Number

-

Brand Name

Lap Scope WarmOR

Version/Model Number

SW-5-12-R

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

-

Product Code

NWV

Product Code Name

Laparoscopic Accessories, Gynecologic

Public Device Record Key

d4e4a6e1-66cd-44fc-ae9f-f8813aa56cd9

Public Version Date

April 04, 2019

Public Version Number

1

DI Record Publish Date

March 27, 2019

Package DI Number

09349967003251

Quantity per Package

8

Contains DI Package

09349967003244

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper