Catalog Number

-

Brand Name

Surgiwip

Version/Model Number

ELW-30

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

K912973,K912973

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

99370773-7c46-46d6-bdf5-5b395552da73

Public Version Date

July 26, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20884521132051

Quantity per Package

6

Contains DI Package

10884521132054

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE