Catalog Number

-

Brand Name

SurgiSleeve

Version/Model Number

WPXSM24

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

K140064,K140064,K140064

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

9dff88c8-3264-487d-98eb-b14a54c253e4

Public Version Date

August 12, 2022

Public Version Number

6

DI Record Publish Date

July 27, 2017

Package DI Number

10884521203792

Quantity per Package

5

Contains DI Package

20884521203799

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK