Catalog Number

-

Brand Name

Disposable Ear Specula Tips

Version/Model Number

7117

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JYG

Product Code Name

Curette, Ear

Public Device Record Key

2c54810a-293e-41d4-add9-5308443d2bab

Public Version Date

May 31, 2021

Public Version Number

1

DI Record Publish Date

May 21, 2021

Package DI Number

00616784711737

Quantity per Package

10

Contains DI Package

00061678471172

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case