Catalog Number

AHS1055NS

Brand Name

Atlanta Healthcare Services OcuDrape®

Version/Model Number

10852171007848

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

-

Product Code

HMT

Product Code Name

Drape, patient, ophthalmic

Public Device Record Key

256dcda6-9d0c-4eee-b5ad-b8a835002a51

Public Version Date

November 07, 2018

Public Version Number

3

DI Record Publish Date

March 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-