Catalog Number

-

Brand Name

BOJRAB TINY TRIUNE

Version/Model Number

510-511

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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,K981575

Product Code

ETD

Product Code Name

Tube, Tympanostomy

Public Device Record Key

68115fec-ba5b-4394-9bb0-f0c6e3b81dfe

Public Version Date

January 22, 2021

Public Version Number

6

DI Record Publish Date

January 26, 2018

Package DI Number

10844505011669

Quantity per Package

5

Contains DI Package

00844505011662

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-