Catalog Number

SMBTTOVLX

Brand Name

Spacemaker

Version/Model Number

SMBTTOVLX

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

K151356,K151356

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

8879397a-45b3-435b-bb77-1f6526383ed5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

20884521545295

Quantity per Package

3

Contains DI Package

10884521545298

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK