Catalog Number

-

Brand Name

SUMMIT MEDICAL

Version/Model Number

2-90-915

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K051157,K133015,K140289,K141513,K142630,K142768,K150540,K151166,K051157,K133015,K140289,K141513,K142630,K142768,K150540,K151166

Product Code

HOZ

Product Code Name

Sponge, Ophthalmic

Public Device Record Key

6139efb8-70bc-470d-8713-60b843720cf0

Public Version Date

August 23, 2021

Public Version Number

4

DI Record Publish Date

January 19, 2021

Package DI Number

10385640063446

Quantity per Package

250

Contains DI Package

00385640063449

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX