Catalog Number

SP100-02

Brand Name

DeRoyal

Version/Model Number

SP100-02

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

-

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

HNC

Product Code Name

Specula, ophthalmic

Public Device Record Key

f02027f8-3e3c-4259-943c-b2c5343c9581

Public Version Date

August 31, 2021

Public Version Number

1

DI Record Publish Date

August 23, 2021

Package DI Number

50749756371358

Quantity per Package

780

Contains DI Package

00749756371353

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case