Catalog Number

2395J

Brand Name

SPECULUM TUBING

Version/Model Number

2395J

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

-

Product Code

FCZ

Product Code Name

TUBE, SMOKE REMOVAL, ENDOSCOPIC

Public Device Record Key

69035b12-45af-4ddd-8aa0-e807f6d148c9

Public Version Date

June 11, 2021

Public Version Number

7

DI Record Publish Date

August 14, 2020

Package DI Number

30614559104600

Quantity per Package

25

Contains DI Package

10614559104606

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX