Catalog Number

-

Brand Name

BOJRAB TINY TRIUNE

Version/Model Number

510-511

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 17, 2018

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

K981575

Product Code

ETD

Product Code Name

TUBE, TYMPANOSTOMY

Public Device Record Key

377e0127-278b-4d04-a588-ceb0f0c78b86

Public Version Date

January 22, 2021

Public Version Number

4

DI Record Publish Date

June 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-