Catalog Number

SCD25-1

Brand Name

Standard Clamp, Disposable

Version/Model Number

SCD25-1

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

K181608,K181608

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

27546f43-85ad-4d5a-a5f2-4bb11550d6aa

Public Version Date

August 21, 2019

Public Version Number

5

DI Record Publish Date

November 07, 2017

Package DI Number

00851677007010

Quantity per Package

4

Contains DI Package

00851677007003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-