Catalog Number

-

Brand Name

ASP MEDICAL

Version/Model Number

OTA402

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

c7b4ca59-5826-4cc7-97bf-0a9616b844e9

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

October 21, 2020

Package DI Number

10840216101750

Quantity per Package

2

Contains DI Package

00840216101753

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER PACK