Catalog Number

-

Brand Name

Lid Speculum

Version/Model Number

11-3001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HOD

Product Code Name

Clamp, Eyelid, Ophthalmic

Public Device Record Key

f22bff06-3f89-4c0a-9e70-f59c60fda023

Public Version Date

June 03, 2022

Public Version Number

1

DI Record Publish Date

May 26, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-