Catalog Number

N207105

Brand Name

Pro Advantage

Version/Model Number

N207105

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

3b710f9d-a345-4ef7-8e8e-2c3fee0fd5ce

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

February 13, 2017

Package DI Number

M220N2071055

Quantity per Package

300

Contains DI Package

M220N2071053

Package Discontinue Date

-

Package Status

-

Package Type

Case