Catalog Number

TSPC-5

Brand Name

Snowden-Pencer

Version/Model Number

TSPC-5

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

-

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

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

30c2e113-3b3d-4de4-87a7-4f1db723d380

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 16, 2018

Package DI Number

70885403465637

Quantity per Package

5

Contains DI Package

10885403465635

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack