Catalog Number

-

Brand Name

OTOMED® SUCTION TUBING

Version/Model Number

SP-4000

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

-

Product Code

GBX

Product Code Name

Catheter, Irrigation

Public Device Record Key

53bb1465-026b-4eac-8a88-d5806ab4594e

Public Version Date

October 08, 2021

Public Version Number

5

DI Record Publish Date

September 21, 2018

Package DI Number

10850000126128

Quantity per Package

6

Contains DI Package

00850000126121

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-