Catalog Number

SORG103XL

Brand Name

Atlanta Healthcare Services OcuDrape®

Version/Model Number

10851736007903

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K931562,K931562

Product Code

FYA

Product Code Name

GOWN, SURGICAL

Public Device Record Key

7f040e7c-247f-41ac-b9c3-3e170f61640e

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

November 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-