Catalog Number

MICFICLOSEDCAP_US

Brand Name

CLOSED CAP FOR FEDMEDMICFIP/P5M/UVW/UVWP/STD

Version/Model Number

BTS-327

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2022

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

ERA

Product Code Name

Otoscope

Public Device Record Key

85458a4b-72b7-43f1-a3f3-7c3d7921d1e5

Public Version Date

September 30, 2022

Public Version Number

2

DI Record Publish Date

October 12, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-